Trial Outcomes & Findings for Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies (NCT NCT04902040)

NCT ID: NCT04902040

Last Updated: 2026-04-30

Results Overview

The number of patients who received treatment and have a partial or complete response to the treatment through study completion.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

19 participants

Primary outcome timeframe

From the baseline tumor assessment through the last on-study tumor assessment for each participant, assessed up to 3 years

Results posted on

2026-04-30

Participant Flow

Recruiting patients with advanced solid tumors between 4/14/2021 and 5/22/2024. Location: MD Anderson in Houston, TX (Medical Clinic)

Phase II was not conducted.

Participant milestones

Participant milestones
Measure	Phase 1b: RTX + Plinabulin (30 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W) Plinabulin (30 mg/m2 iv, Q3W on C1D1, C1D4, C2D1…), Pembrolizumab (200 mg iv Q3W)	Phase 1b: RTX + Plinabulin (30 mg/m2, Q4W) + Nivolumab (240 mg, Q2W) Palinabulin (30 mg/m2 iv, Q3W on C1D1, C1D4, C2D1…), Nivolumab (240 mg iv Q2W)
Overall Study STARTED	14	5
Overall Study Plinabulin Reduced to 20 mg/m2	2	0
Overall Study COMPLETED	14	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b: RTX + Plinabulin (30 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W) n=14 Participants Plinabulin (30 mg/m2 iv, Q3W on C1D1, C1D4, C2D1…), Pembrolizumab (200 mg iv Q3W)	Phase 1b: RTX + Plinabulin (30 mg/m2, Q4W) + Nivolumab (240 mg, Q2W) n=5 Participants Plinabulin (30 mg/m2 iv, Q4W on C1D1, C1D4, C2D1…), Nivolumab (240 mg iv Q2W)	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=14 Participants	0 Participants n=34 Participants	0 Participants n=69 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=14 Participants	4 Participants n=34 Participants	10 Participants n=69 Participants
Age, Categorical >=65 years	8 Participants n=14 Participants	1 Participants n=34 Participants	9 Participants n=69 Participants
Sex: Female, Male Female	6 Participants n=14 Participants	3 Participants n=34 Participants	9 Participants n=69 Participants
Sex: Female, Male Male	8 Participants n=14 Participants	2 Participants n=34 Participants	10 Participants n=69 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=14 Participants	1 Participants n=34 Participants	2 Participants n=69 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=14 Participants	4 Participants n=34 Participants	17 Participants n=69 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=34 Participants	0 Participants n=69 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants	0 Participants n=34 Participants	0 Participants n=69 Participants
Race (NIH/OMB) Asian	1 Participants n=14 Participants	1 Participants n=34 Participants	2 Participants n=69 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	0 Participants n=34 Participants	0 Participants n=69 Participants
Race (NIH/OMB) Black or African American	0 Participants n=14 Participants	1 Participants n=34 Participants	1 Participants n=69 Participants
Race (NIH/OMB) White	12 Participants n=14 Participants	3 Participants n=34 Participants	15 Participants n=69 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=34 Participants	0 Participants n=69 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=14 Participants	0 Participants n=34 Participants	1 Participants n=69 Participants
Region of Enrollment United States	14 participants n=14 Participants	5 participants n=34 Participants	19 participants n=69 Participants

PRIMARY outcome

Timeframe: From the baseline tumor assessment through the last on-study tumor assessment for each participant, assessed up to 3 years

The number of patients who received treatment and have a partial or complete response to the treatment through study completion.

Outcome measures

Outcome measures
Measure	Phase 1b: RTX + Plinabulin (30 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W) n=14 Participants Plinabulin (30 mg/m2 iv, Q3W on C1D1, C1D4, C2D1…), Pembrolizumab (200 mg iv Q3W)	Phase 1b: RTX + Plinabulin (30 mg/m2, Q4W) + Nivolumab (240 mg, Q2W) n=5 Participants Plinabulin (30 mg/m2 iv, Q3W on C1D1, C1D4, C2D1…), Nivolumab (240 mg iv Q2W)
Objective Tumor Response Rate (ORR) (Complete Response + Partial Response).	2 participants	2 participants

SECONDARY outcome

Timeframe: From the baseline tumor assessment through the last on-study tumor assessment for each participant, assessed up to 3 years

Population: The number of Participants who received first dose of study treatment and performed at least one time of on-study tumor assessment.

The number of patients who received treatment and have a partial or complete response, or stabe disease to the treatment assessed according to irRECIST criteria through study completion.

Outcome measures

Outcome measures
Measure	Phase 1b: RTX + Plinabulin (30 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W) n=14 Participants Plinabulin (30 mg/m2 iv, Q3W on C1D1, C1D4, C2D1…), Pembrolizumab (200 mg iv Q3W)	Phase 1b: RTX + Plinabulin (30 mg/m2, Q4W) + Nivolumab (240 mg, Q2W) n=5 Participants Plinabulin (30 mg/m2 iv, Q3W on C1D1, C1D4, C2D1…), Nivolumab (240 mg iv Q2W)
To Assess Disease Control Rate (Complete Response [CR] + Partial Response [PR] + Stable Disease [SD]).	6 Participants	2 Participants

Adverse Events

Phase 1b: RTX + Plinabulin (30 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W)

Serious events: 9 serious events

Other events: 14 other events

Deaths: 2 deaths

Phase 1b: RTX + Plinabulin (20 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Phase 1b: RTX + Plinabulin (30 mg/m2, Q4W) + Nivolumab (240 mg, Q2W)

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Siqing Fu, MD,PHD

The University of Texas MD Anderson Cancer Center

Phone: (713) 792-4318

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Phase 1b: RTX + Plinabulin (30 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W) n=14 participants at risk Plinabulin (30 mg/m2 iv, Q3W on C1D1, C1D4, C2D1…), Pembrolizumab (200 mg iv Q3W)	Phase 1b: RTX + Plinabulin (20 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W) n=2 participants at risk Plinabulin (20 mg/m2 iv, Q3W on C1D1, C1D4, C2D1…), Pembrolizumab (200 mg iv Q3W)	Phase 1b: RTX + Plinabulin (30 mg/m2, Q4W) + Nivolumab (240 mg, Q2W) n=5 participants at risk Plinabulin (30 mg/m2 iv, Q4W on C1D1, C1D4, C2D1…), Nivolumab (240 mg iv Q2W)
Vascular disorders Anemia	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Gastrointestinal disorders Abdominal pain	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Nervous system disorders Agitation	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Investigations Alanine aminotransferase increased	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Investigations Aspartate aminotransferase increased	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Cardiac disorders Chest pain	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
General disorders Fall	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
General disorders Fever	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Gastrointestinal disorders Gastric hemorrhage	14.3% 2/14 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	50.0% 1/2 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Vascular disorders Hypertension	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
General disorders Infusion related reaction	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	50.0% 1/2 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Respiratory, thoracic and mediastinal disorders Lung infection	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Cardiac disorders Myocarditis	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Blood and lymphatic system disorders Neutrophil count decreased	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Blood and lymphatic system disorders Platelet count decreased	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Nervous system disorders Altered mental status	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Respiratory, thoracic and mediastinal disorders Respiratory failure	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Cardiac disorders Ventricular arrhythmia	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Gastrointestinal disorders Small intestinal obstruction	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Blood and lymphatic system disorders WBC decreased	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/14 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.

Other adverse events
Measure	Phase 1b: RTX + Plinabulin (30 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W) n=14 participants at risk Plinabulin (30 mg/m2 iv, Q3W on C1D1, C1D4, C2D1…), Pembrolizumab (200 mg iv Q3W)	Phase 1b: RTX + Plinabulin (20 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W) n=2 participants at risk Plinabulin (20 mg/m2 iv, Q3W on C1D1, C1D4, C2D1…), Pembrolizumab (200 mg iv Q3W)	Phase 1b: RTX + Plinabulin (30 mg/m2, Q4W) + Nivolumab (240 mg, Q2W) n=5 participants at risk Plinabulin (30 mg/m2 iv, Q4W on C1D1, C1D4, C2D1…), Nivolumab (240 mg iv Q2W)
Gastrointestinal disorders Abdominal pain	14.3% 2/14 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Investigations Alanine aminotransferase increased	42.9% 6/14 • Number of events 9 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	50.0% 1/2 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Blood and lymphatic system disorders Anemia	35.7% 5/14 • Number of events 5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	50.0% 1/2 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	40.0% 2/5 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Metabolism and nutrition disorders Anorexia	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Musculoskeletal and connective tissue disorders Arthritis	7.1% 1/14 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
General disorders Chills	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Investigations Aspartate aminotransferase increased	28.6% 4/14 • Number of events 7 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Cardiac disorders Cardiac disorders - Other, specify: Arrythmia	14.3% 2/14 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Cardiac disorders Cardiac troponin increased	14.3% 2/14 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Gastrointestinal disorders Colitis	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Gastrointestinal disorders Diarrhea	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	50.0% 1/2 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Nervous system disorders Dizziness	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
General disorders Dry eye	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Gastrointestinal disorders Dry mouth	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
General disorders Eye disorders - Other, specify: vision disturbance	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
General disorders Fatigue	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	40.0% 2/5 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Nervous system disorders Headache	14.3% 2/14 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	40.0% 2/5 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Respiratory, thoracic and mediastinal disorders Hoarseness	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Investigations Hypercalcemia	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Vascular disorders Hypertension	71.4% 10/14 • Number of events 20 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	50.0% 1/2 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	60.0% 3/5 • Number of events 13 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Metabolism and nutrition disorders Hypoalbuminemia	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/5 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Blood and lymphatic system disorders Lymphocyte count decreased	85.7% 12/14 • Number of events 23 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	50.0% 1/2 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	100.0% 5/5 • Number of events 6 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Gastrointestinal disorders Nausea	50.0% 7/14 • Number of events 8 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	60.0% 3/5 • Number of events 3 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Blood and lymphatic system disorders Neutrophil count decreased	14.3% 2/14 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	40.0% 2/5 • Number of events 9 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Nervous system disorders Pain	21.4% 3/14 • Number of events 3 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Blood and lymphatic system disorders Platelet count decreased	28.6% 4/14 • Number of events 8 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	40.0% 2/5 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: rash	7.1% 1/14 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	40.0% 2/5 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Gastrointestinal disorders Vomiting	28.6% 4/14 • Number of events 4 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	40.0% 2/5 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Blood and lymphatic system disorders White blood cell decreased	28.6% 4/14 • Number of events 6 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Gastrointestinal disorders Constipation	0.00% 0/14 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/14 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Investigations Creatinine increased	0.00% 0/14 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Skin and subcutaneous tissue disorders Dermatitis radiation	0.00% 0/14 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
General disorders Fever	0.00% 0/14 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
General disorders Infusion related reaction	0.00% 0/14 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Musculoskeletal and connective tissue disorders Muscle cramp	0.00% 0/14 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
General disorders Non-cardiac chest pain	0.00% 0/14 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/14 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	0.00% 0/2 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.	20.0% 1/5 • Number of events 1 • From first dose of study treatment through 30 days post last dose of study treatment for each participant, evaluated up to 3 years Treatment emergent AEs were recorded that occurred after fisrt dose of study treatment through 30 days post last dose of study treatment, and/or any treatment-related AE, regardless of the onset date. AE evaluated according to CTCAE version 5.0, and summarized by severity by dose level.