Trial Outcomes & Findings for Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics (NCT NCT04315233)

Last Updated: 2026-09-04

Results Overview

This outcome measure will report the count of participants who experienced DLTs during the DLT period. The DLT period is defined as the first cycle of treatment (from cycle one day one dosing to cycle two day 1). Patients will be assessed over this period for the occurrence of adverse events, per CTCAE v5.0. Any of the following events occurring within the defined DLT period which are attributable (possibly, probably, or definitely related) to any or all agents in the combination will be classified as a DLT: * Hematologic: * Grade 3 Thrombocytopenia with clinically significant bleeding * Grade 4-5 Thrombocytopenia * Grade ≥ 3 Febrile Neutropenia * Grade 4-5 Neutropenia lasting \>7 days * Non-Hematologic: * Any grade ≥ 4 toxicity * Any grade 3 toxicity lasting \>48 hours despite maximal medical therapy except for clinically non-significant laboratory abnormalities. * Grade ≥ 3 Electrocardiogram (ECG) corrected QT interval by Fredericia (QTcF) prolongation

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

up to 28 days after initiation of study treatment

Results posted on

2026-09-04

Participant Flow

No participants were enrolled in Cohort 1: Dose Level 2 or Cohort 2.

Participant milestones

Participant milestones
Measure	Cohort 1: Dose Level 0 Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 0 (starting dose) 200mg QD Belinostat: Belinostat Dose Level 0 (starting dose) 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1A Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1A 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1A 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1B Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 200mg QD Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.
Overall Study STARTED	3	6	3
Overall Study COMPLETED	3	6	3
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Dose Level 0 n=3 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 0 (starting dose) 200mg QD Belinostat: Belinostat Dose Level 0 (starting dose) 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1A n=6 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1A 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1A 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1B n=3 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 200mg QD Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 2 Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 2: Dose Expansion Cohort The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=23 Participants	2 Participants n=23 Participants	3 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	6 Participants n=113 Participants
Age, Categorical >=65 years	2 Participants n=23 Participants	4 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	6 Participants n=113 Participants
Age, Continuous	65 years STANDARD_DEVIATION 7.09 • n=23 Participants	69.50 years STANDARD_DEVIATION 15.26 • n=23 Participants	61.00 years STANDARD_DEVIATION 11.85 • n=22 Participants	—	—	63.50 years STANDARD_DEVIATION 12.93 • n=113 Participants
Sex: Female, Male Female	3 Participants n=23 Participants	6 Participants n=23 Participants	3 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	12 Participants n=113 Participants
Sex: Female, Male Male	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=23 Participants	0 Participants n=23 Participants	00 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	1 Participants n=113 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=23 Participants	6 Participants n=23 Participants	3 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	11 Participants n=113 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants
Race (NIH/OMB) Asian	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants
Race (NIH/OMB) Black or African American	0 Participants n=23 Participants	0 Participants n=23 Participants	1 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	1 Participants n=113 Participants
Race (NIH/OMB) White	3 Participants n=23 Participants	6 Participants n=23 Participants	2 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	11 Participants n=113 Participants
Race (NIH/OMB) More than one race	00 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants
Region of Enrollment United States	3 Participants n=23 Participants	6 Participants n=23 Participants	3 Participants n=22 Participants	—	—	12 Participants n=113 Participants
Metastatic at initial diagnosis Yes	1 Participants n=23 Participants	1 Participants n=23 Participants	2 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	4 Participants n=113 Participants
Metastatic at initial diagnosis No	2 Participants n=23 Participants	5 Participants n=23 Participants	1 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	8 Participants n=113 Participants
Nottingham combined histologic grade G1: Low combined histologic grade (favorable); SBR score of 3-5 points	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants
Histopathologic Type Ovarian-serous carcinoma	2 Participants n=23 Participants	3 Participants n=23 Participants	1 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	6 Participants n=113 Participants
Histopathologic Type Breast-invasive ductal carcinoma	1 Participants n=23 Participants	3 Participants n=23 Participants	2 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	6 Participants n=113 Participants
Nottingham combined histologic grade G2: Intermediate combined histologic grade (moderately favorable); SBR score of 6-7 points	1 Participants n=23 Participants	2 Participants n=23 Participants	1 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	4 Participants n=113 Participants
Nottingham combined histologic grade G3: High combined histologic grade (unfavorable); SBR score of 8-9 points	2 Participants n=23 Participants	4 Participants n=23 Participants	2 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=24 Participants	8 Participants n=113 Participants
Nottingham combined histologic grade 0GX: Grade cannot be assessed	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	00 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=113 Participants
Number of Lines of Therapy Completed Before Enrollment	4 Lines of Therapy STANDARD_DEVIATION 3.21 • n=23 Participants	5 Lines of Therapy STANDARD_DEVIATION 2.04 • n=23 Participants	4 Lines of Therapy STANDARD_DEVIATION 1.53 • n=22 Participants	—	—	4.5 Lines of Therapy STANDARD_DEVIATION 4.5 • n=113 Participants
Height	165.10 cm STANDARD_DEVIATION 4.56 • n=23 Participants	161.30 cm STANDARD_DEVIATION 8.98 • n=23 Participants	162.60 cm STANDARD_DEVIATION 10.15 • n=22 Participants	—	—	163.85 cm STANDARD_DEVIATION 8 • n=113 Participants
Weight	59.70 kg STANDARD_DEVIATION 3.59 • n=23 Participants	69.35 kg STANDARD_DEVIATION 16.56 • n=23 Participants	67.60 kg STANDARD_DEVIATION 15.07 • n=22 Participants	—	—	66.40 kg STANDARD_DEVIATION 13.95 • n=113 Participants
BMI	21.50 kg/m^2 STANDARD_DEVIATION 2.51 • n=23 Participants	25.90 kg/m^2 STANDARD_DEVIATION 7.24 • n=23 Participants	25.57 kg/m^2 STANDARD_DEVIATION 3.02 • n=22 Participants	—	—	25.48 kg/m^2 STANDARD_DEVIATION 5.86 • n=113 Participants

PRIMARY outcome

Timeframe: up to 28 days after initiation of study treatment

Population: No participants were enrolled in Cohort 1: Dose Level 2 or Cohort 2.

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 0 n=3 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 0 (starting dose) 200mg QD Belinostat: Belinostat Dose Level 0 (starting dose) 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1A n=6 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1A 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1A 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1B n=3 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 200mg QD Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 2 Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 2: Dose Expansion Cohort The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion
Rate of Dose Limiting Toxicity (DLT)	0 Participants	1 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: up to 5 months from the start of study treatment

Population: No participants were enrolled in Cohort 1 Dose Level 2 and Cohort 2

To assess the safety of ribociclib and belinostat in combination. This outcome measure will report the count of participants who experienced an Grade 3 or higher Adverse Event (AE) or Serious Adverse Event (SAE) related to ribociclib and belinostat. Events with a Definite, Probable, or Possible attribution were considered attributed to ribociclib and belinostatin.

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 0 n=3 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 0 (starting dose) 200mg QD Belinostat: Belinostat Dose Level 0 (starting dose) 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1A n=6 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1A 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1A 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1B n=3 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 200mg QD Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 2 Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 2: Dose Expansion Cohort The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion
Frequency of Attributed Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with a Grade 3 or higher AE Attributed to Ribociclib	1 Participants	3 Participants	3 Participants	—	—
Frequency of Attributed Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with a Grade 3 or higher AE Attributed to Belinostat	2 Participants	3 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: up to 4 months

Population: No participants were enrolled in Cohort 1 Dose Level 2 and Cohort 2

To assess the efficacy in the study population. Progression-free survival (PFS) is defined as the time from study drug initiation to the time of documented disease progression (as assessed by RECIST 1.1) or death from any cause.

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 0 n=3 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 0 (starting dose) 200mg QD Belinostat: Belinostat Dose Level 0 (starting dose) 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1A n=6 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1A 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1A 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1B n=3 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 200mg QD Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 2 Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 2: Dose Expansion Cohort The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion
Progression Free Survival (PFS)	49 days Standard Deviation 5.86	63 days Standard Deviation 26.18	12 days Standard Deviation 33.5	—	—

SECONDARY outcome

Timeframe: up to 4 months

Population: No participants were enrolled in Cohort 1: Dose Level 2 or Cohort 2.

To assess the efficacy in the study population. Objective response rate is defined as the proportion of patients achieving CR (Complete Response) or PR (Partial Response), as assessed by RECIST 1.1 while on study treatment. CR was defined as a the disappearance of all target lesions and non-target lesions. PR was defined as a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD, for a minimum of four weeks.

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 0 n=3 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 0 (starting dose) 200mg QD Belinostat: Belinostat Dose Level 0 (starting dose) 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1A n=6 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1A 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1A 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1B n=3 Participants Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 200mg QD Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 2 Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 2: Dose Expansion Cohort The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion
Objective Response Rate (ORR)	0 proportion of patients achieving PR/CR	0 proportion of patients achieving PR/CR	0 proportion of patients achieving PR/CR	—	—

Adverse Events

Cohort 1: Dose Level 0

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Cohort 1: Dose Level 1A

Serious events: 6 serious events

Other events: 6 other events

Deaths: 5 deaths

Cohort 1: Dose Level 1B

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Cohort 1: Dose Level 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2: Dose Expansion Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Dose Level 0 n=3 participants at risk Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 0 (starting dose) 200mg QD Belinostat: Belinostat Dose Level 0 (starting dose) 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1A n=6 participants at risk Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1A 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1A 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1B n=3 participants at risk Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 200mg QD Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 2 Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 2: Dose Expansion Cohort The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion
General disorders Fever	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Cardiac disorders Atrial fibrillation	33.3% 1/3 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Investigations Blood bilirubin increased	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Colonic obstruction	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Constipation	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
General disorders Disease progression	66.7% 2/3 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	50.0% 3/6 • Number of events 3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	66.7% 2/3 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
General disorders Edema face	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Infections and infestations Enterocolitis infectious	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Infections and infestations Lung infection	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Nervous system disorders Muscle weakness right-sided	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
General disorders Non-cardiac chest pain	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Infections and infestations Sepsis	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Infections and infestations Soft tissue infection	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.

Other adverse events

Other adverse events
Measure	Cohort 1: Dose Level 0 n=3 participants at risk Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 0 (starting dose) 200mg QD Belinostat: Belinostat Dose Level 0 (starting dose) 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1A n=6 participants at risk Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1A 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1A 600mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 1B n=3 participants at risk Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 200mg QD Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 1: Dose Level 2 Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. Ribociclib: Ribociclib Dose Level 1B 400mg QD on Days 8-28 Belinostat: Belinostat Dose Level 1B 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.	Cohort 2: Dose Expansion Cohort The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	50.0% 3/6 • Number of events 6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Immune system disorders Allergic reaction	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Bloating	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Eye disorders Blurred vision	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
General disorders Chills	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	100.0% 6/6 • Number of events 17 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Nervous system disorders Dizziness	66.7% 2/3 • Number of events 4 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Dry mouth	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Nervous system disorders Dysgeusia	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	50.0% 3/6 • Number of events 4 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
General disorders Edema face	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
General disorders Edema limbs	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	50.0% 3/6 • Number of events 6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 4 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
General disorders Fatigue	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	50.0% 3/6 • Number of events 3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	66.7% 2/3 • Number of events 3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
General disorders Fever	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Flatulence	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
General disorders Flu like symptoms	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Injury, poisoning and procedural complications Fracture	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
General disorders Gait disturbance	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Nervous system disorders Headache	33.3% 1/3 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	66.7% 4/6 • Number of events 4 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Vascular disorders Hot flashes	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Vascular disorders Hypertension	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Metabolism and nutrition disorders Hypomagnesemia	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Vascular disorders Hypotension	66.7% 2/3 • Number of events 3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
General disorders Injection site reaction	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Psychiatric disorders Insomnia	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Infections and infestations Lung infection	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Musculoskeletal and connective tissue disorders Muscle cramp	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	83.3% 5/6 • Number of events 8 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	66.7% 2/3 • Number of events 3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Investigations Neutrophil count decreased	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Oral pain	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
General disorders Pain	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	50.0% 3/6 • Number of events 4 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Reproductive system and breast disorders Pelvic pain	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Investigations Platelet count decreased	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Nervous system disorders Somnolence	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Stomach pain	66.7% 2/3 • Number of events 4 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 2 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Surgical and medical procedures Surgical and medical procedures - Other, specify	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	33.3% 2/6 • Number of events 8 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Vascular disorders Thromboembolic event	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Infections and infestations Thrush	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/6 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Renal and urinary disorders Urinary frequency	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Infections and infestations Urinary tract infection	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	66.7% 4/6 • Number of events 7 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	66.7% 2/3 • Number of events 3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Investigations Weight loss	33.3% 1/3 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.
Investigations White blood cell decreased	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	16.7% 1/6 • Number of events 1 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	0.00% 0/3 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.	— 0/0 • All subjects were followed for 30 days after the last dose of study medication for adverse events, up to 3 months from the study treatment start date. All subjects were followed for 90 days after the last dose of study medication for serious adverse events, up to 5 months from the study treatment start date. All subjects were followed for up to 2 years after the last dose of study medication for Overall Survival, up to 27 months from the study treatment start date. No subjects were enrolled in Cohort 1 Dose Level 2 or Cohort 2.

Additional Information

IIT Data Management Team

Research Compliance Office, Huntsman Cancer Institute

Phone: 801-213-6215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60