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Trial Outcomes & Findings for Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer (NCT NCT04674306)

NCT ID: NCT04674306

Last Updated: 2026-07-17

Results Overview

MTD of an α-lactalbumin vaccine in participants with operable triple-negative breast cancer

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

35 participants

Primary outcome timeframe

Day 84

Results posted on

2026-07-17

Participant Flow

Participant milestones

Participant milestones
Measure
Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1b: 50ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1e: 10ug aLa and 20ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 2\*: 100ug aLa and 100ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 2: 100ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 3: 500ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1b at Dose Level 1: Preventitive A-lactalbumin (aLa) and Zymosan
Cohort 1b participants are with a BRCA1.BRCA2, or PALB2 mutation undergoing risk reducing mastectomy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1c at Dose Level 1: Standard of Care With A-lactalbumin (aLa) and Zymosan
Cohort 1c participants are undergoing chemo immunotherpay for operable TNBC. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Overall Study
STARTED
6
5
5
1
6
3
4
5
Overall Study
COMPLETED
6
5
5
0
6
3
4
5
Overall Study
NOT COMPLETED
0
0
0
1
0
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1b: 50ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1e: 10ug aLa and 20ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 2\*: 100ug aLa and 100ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 2: 100ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 3: 500ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1b at Dose Level 1: Preventitive A-lactalbumin (aLa) and Zymosan
Cohort 1b participants are with a BRCA1.BRCA2, or PALB2 mutation undergoing risk reducing mastectomy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1c at Dose Level 1: Standard of Care With A-lactalbumin (aLa) and Zymosan
Cohort 1c participants are undergoing chemo immunotherpay for operable TNBC. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Overall Study
Adverse Event
0
0
0
1
0
0
0
0

Baseline Characteristics

Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan
n=6 Participants
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan
n=5 Participants
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1b: 50ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan
n=5 Participants
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1e: 10ug aLa and 20ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan
n=1 Participants
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 2\*: 100ug aLa and 100ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan
n=6 Participants
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 2: 100ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan
n=3 Participants
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 3: 500ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1b at Dose Level 1: Preventitive A-lactalbumin (aLa) and Zymosan
n=4 Participants
Cohort 1b participants are with a BRCA1.BRCA2, or PALB2 mutation undergoing risk reducing mastectomy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1c at Dose Level 1: Standard of Care With A-lactalbumin (aLa) and Zymosan
n=5 Participants
Cohort 1c participants are undergoing chemo immunotherpay for operable TNBC. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Total
n=35 Participants
Total of all reporting groups
Age, Customized
50-59 years
1 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
1 Participants
n=5 Participants
2 Participants
n=9 Participants
1 Participants
n=6 Participants
1 Participants
n=6 Participants
1 Participants
n=6 Participants
7 Participants
n=5 Participants
Age, Customized
30-39 years
0 Participants
n=20 Participants
1 Participants
n=20 Participants
1 Participants
n=40 Participants
0 Participants
n=5 Participants
1 Participants
n=9 Participants
0 Participants
n=6 Participants
2 Participants
n=6 Participants
1 Participants
n=6 Participants
6 Participants
n=5 Participants
Age, Customized
40-49 years
1 Participants
n=20 Participants
2 Participants
n=20 Participants
3 Participants
n=40 Participants
0 Participants
n=5 Participants
0 Participants
n=9 Participants
1 Participants
n=6 Participants
1 Participants
n=6 Participants
1 Participants
n=6 Participants
9 Participants
n=5 Participants
Age, Customized
60-69 years
4 Participants
n=20 Participants
1 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=5 Participants
1 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
2 Participants
n=6 Participants
8 Participants
n=5 Participants
Age, Customized
70-79 years
0 Participants
n=20 Participants
1 Participants
n=20 Participants
1 Participants
n=40 Participants
0 Participants
n=5 Participants
2 Participants
n=9 Participants
1 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
5 Participants
n=5 Participants
Sex: Female, Male
Female
6 Participants
n=20 Participants
5 Participants
n=20 Participants
5 Participants
n=40 Participants
1 Participants
n=5 Participants
6 Participants
n=9 Participants
3 Participants
n=6 Participants
4 Participants
n=6 Participants
5 Participants
n=6 Participants
35 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=5 Participants
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=5 Participants
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
1 Participants
n=6 Participants
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
n=20 Participants
5 Participants
n=20 Participants
5 Participants
n=40 Participants
1 Participants
n=5 Participants
6 Participants
n=9 Participants
3 Participants
n=6 Participants
4 Participants
n=6 Participants
3 Participants
n=6 Participants
33 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=5 Participants
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
1 Participants
n=6 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=5 Participants
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=5 Participants
1 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=5 Participants
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=5 Participants
1 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
6 Participants
n=20 Participants
4 Participants
n=20 Participants
5 Participants
n=40 Participants
1 Participants
n=5 Participants
4 Participants
n=9 Participants
3 Participants
n=6 Participants
4 Participants
n=6 Participants
4 Participants
n=6 Participants
31 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=20 Participants
1 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=5 Participants
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=5 Participants
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
1 Participants
n=6 Participants
1 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 84

Population: This outcome measure only applies to Cohort 1a (treatment cohort).

MTD of an α-lactalbumin vaccine in participants with operable triple-negative breast cancer

Outcome measures

Outcome measures
Measure
Treatment α-lactalbumin and Zymosan
n=26 Participants
Participants with TNBC will be treated with successively higher doses of α-lactalbumin and zymosan in a 3+3 trial design. Treatment involves 3 vaccinations every 2 weeks. Participants will be enrolled in 1 of 5 dose levels until the MTD is identified (intra-patient dose escalation not permitted), after which it'll be expanded to 6 participants. Successively lower doses will be expanded to 6 participants until lowest DL associated with immune response has been expanded. DL1: 10 mcg a-lactalbumin + 10 mcg Zymosan Original DL2:100 mcg a-lactalbumin + 100 mcg Zyomsan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1e: 10 mcg a-lactalbumin + 20 mcg Zymosan DL1f: 20 mcg a-lactalbumin + 10 mcg Zymosan DL1g: 20 mcg a-lactalbumin + 10 mcg Zymosan (if DL1e is too toxic) α-lactalbumin vaccine: α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). DL1: 10 mcg DL Original 2: 100 mcg DL2: 100 mcg DL3: 500 mcg D1b: 50 mcg D1e: 10 mcg D1f: 20 mcg D1g: 20 mcg (D1g will only be utilized if D1c is deemed too toxic) Zymosan: Adjuvant used in vaccine preparation DL1: 10 mcg DL Original 2: 100 mcg DL2: 10 mcg DL3: 10 mcg D1b: 10 mcg D1e: 20 mcg D1f: 20 mcg D1g: 1o mcg (D1g will only be utilized if D1c is deemed too toxic)
Treatment Cohort MTD of α-lactalbumin Vaccine
alpha lactalbumin
10 microgram (mcg)
Treatment Cohort MTD of α-lactalbumin Vaccine
zymosan
10 microgram (mcg)

PRIMARY outcome

Timeframe: Day 84

Population: This outcome measure only applies to Cohort 1b (preventative cohort). This measurement was not achieved as only 4 people were enrolled to this cohort, and per protocol 6 participants must be enrolled to determine a MTD.

MTD of an α-lactalbumin vaccine in participants at risk for TNBC who are scheduled for prophylactic double mastectomy.

Outcome measures

Outcome measures
Measure
Treatment α-lactalbumin and Zymosan
n=4 Participants
Participants with TNBC will be treated with successively higher doses of α-lactalbumin and zymosan in a 3+3 trial design. Treatment involves 3 vaccinations every 2 weeks. Participants will be enrolled in 1 of 5 dose levels until the MTD is identified (intra-patient dose escalation not permitted), after which it'll be expanded to 6 participants. Successively lower doses will be expanded to 6 participants until lowest DL associated with immune response has been expanded. DL1: 10 mcg a-lactalbumin + 10 mcg Zymosan Original DL2:100 mcg a-lactalbumin + 100 mcg Zyomsan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1e: 10 mcg a-lactalbumin + 20 mcg Zymosan DL1f: 20 mcg a-lactalbumin + 10 mcg Zymosan DL1g: 20 mcg a-lactalbumin + 10 mcg Zymosan (if DL1e is too toxic) α-lactalbumin vaccine: α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). DL1: 10 mcg DL Original 2: 100 mcg DL2: 100 mcg DL3: 500 mcg D1b: 50 mcg D1e: 10 mcg D1f: 20 mcg D1g: 20 mcg (D1g will only be utilized if D1c is deemed too toxic) Zymosan: Adjuvant used in vaccine preparation DL1: 10 mcg DL Original 2: 100 mcg DL2: 10 mcg DL3: 10 mcg D1b: 10 mcg D1e: 20 mcg D1f: 20 mcg D1g: 1o mcg (D1g will only be utilized if D1c is deemed too toxic)
Preventative Cohort MTD of α-lactalbumin Vaccine
NA microgram (mcg)
This outcome measure only applies to Cohort 1b (preventative cohort). This measurement was not achieved as only 4 people were enrolled to this cohort, and per protocol 6 participants must be enrolled to determine a MTD.

PRIMARY outcome

Timeframe: Day 84

Population: This outcome measure only applies to Cohort 1c (Standard of Care/pembrolizumab cohort). This measurement was not achieved as only 5 people were enrolled to this cohort, and per protocol 6 participants must be enrolled to determine a MTD

MTD of an α-lactalbumin vaccine in participants who are receiving adjuvant pembrolizumab following initial TNBC treatment.

Outcome measures

Outcome measures
Measure
Treatment α-lactalbumin and Zymosan
n=5 Participants
Participants with TNBC will be treated with successively higher doses of α-lactalbumin and zymosan in a 3+3 trial design. Treatment involves 3 vaccinations every 2 weeks. Participants will be enrolled in 1 of 5 dose levels until the MTD is identified (intra-patient dose escalation not permitted), after which it'll be expanded to 6 participants. Successively lower doses will be expanded to 6 participants until lowest DL associated with immune response has been expanded. DL1: 10 mcg a-lactalbumin + 10 mcg Zymosan Original DL2:100 mcg a-lactalbumin + 100 mcg Zyomsan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1e: 10 mcg a-lactalbumin + 20 mcg Zymosan DL1f: 20 mcg a-lactalbumin + 10 mcg Zymosan DL1g: 20 mcg a-lactalbumin + 10 mcg Zymosan (if DL1e is too toxic) α-lactalbumin vaccine: α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). DL1: 10 mcg DL Original 2: 100 mcg DL2: 100 mcg DL3: 500 mcg D1b: 50 mcg D1e: 10 mcg D1f: 20 mcg D1g: 20 mcg (D1g will only be utilized if D1c is deemed too toxic) Zymosan: Adjuvant used in vaccine preparation DL1: 10 mcg DL Original 2: 100 mcg DL2: 10 mcg DL3: 10 mcg D1b: 10 mcg D1e: 20 mcg D1f: 20 mcg D1g: 1o mcg (D1g will only be utilized if D1c is deemed too toxic)
Pembrolizumab Cohort of α-lactalbumin Vaccine
NA microgram (mcg)
This outcome measure only applies to Cohort 1c (Standard of Care/pembrolizumab cohort). This measurement was not achieved as only 5 people were enrolled to this cohort, and per protocol 6 participants must be enrolled to determine a MTD

SECONDARY outcome

Timeframe: Day 84

Population: This outcome measure only applies to Cohort 1a (treatment cohort).

LID of α-lactalbumin vaccine in participants with operable triple-negative breast cancer, based on ELISPOT assays to assess the ability to induce a pro-inflammatory T cell response consistent with tumor protection. This assessment will be determined using the ELISPOT assay to determine peripheral blood frequencies of T cells that produce interferon-gamma (IFNγ; type-1) and IL-17 (type-17) in response to recombinant human α-lactalbumin

Outcome measures

Outcome measures
Measure
Treatment α-lactalbumin and Zymosan
n=26 Participants
Participants with TNBC will be treated with successively higher doses of α-lactalbumin and zymosan in a 3+3 trial design. Treatment involves 3 vaccinations every 2 weeks. Participants will be enrolled in 1 of 5 dose levels until the MTD is identified (intra-patient dose escalation not permitted), after which it'll be expanded to 6 participants. Successively lower doses will be expanded to 6 participants until lowest DL associated with immune response has been expanded. DL1: 10 mcg a-lactalbumin + 10 mcg Zymosan Original DL2:100 mcg a-lactalbumin + 100 mcg Zyomsan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1e: 10 mcg a-lactalbumin + 20 mcg Zymosan DL1f: 20 mcg a-lactalbumin + 10 mcg Zymosan DL1g: 20 mcg a-lactalbumin + 10 mcg Zymosan (if DL1e is too toxic) α-lactalbumin vaccine: α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). DL1: 10 mcg DL Original 2: 100 mcg DL2: 100 mcg DL3: 500 mcg D1b: 50 mcg D1e: 10 mcg D1f: 20 mcg D1g: 20 mcg (D1g will only be utilized if D1c is deemed too toxic) Zymosan: Adjuvant used in vaccine preparation DL1: 10 mcg DL Original 2: 100 mcg DL2: 10 mcg DL3: 10 mcg D1b: 10 mcg D1e: 20 mcg D1f: 20 mcg D1g: 1o mcg (D1g will only be utilized if D1c is deemed too toxic)
Treatment Cohort Lowest Immunologic Dose (LID) of α-lactalbumin Vaccine
alpha lactalbumin
10 micrograms (mcg)
Treatment Cohort Lowest Immunologic Dose (LID) of α-lactalbumin Vaccine
zymosan
10 micrograms (mcg)

SECONDARY outcome

Timeframe: Day 84

Population: This outcome measure only applies to Cohort 1b (prevention cohort). This measurement was not achieved as only 4 people were enrolled to this cohort, and per protocol 6 participants must be enrolled to determine a LID.

LID of α-lactalbumin vaccine in participants at risk for TNBC who are scheduled for prophylactic double mastectomy, based on ELISPOT assays to assess the ability to induce a pro-inflammatory T cell response consistent with tumor protection. This assessment will be determined using the ELISPOT assay to determine peripheral blood frequencies of T cells that produce interferon-gamma (IFNγ; type-1) and IL-17 (type-17) in response to recombinant human α-lactalbumin

Outcome measures

Outcome measures
Measure
Treatment α-lactalbumin and Zymosan
n=4 Participants
Participants with TNBC will be treated with successively higher doses of α-lactalbumin and zymosan in a 3+3 trial design. Treatment involves 3 vaccinations every 2 weeks. Participants will be enrolled in 1 of 5 dose levels until the MTD is identified (intra-patient dose escalation not permitted), after which it'll be expanded to 6 participants. Successively lower doses will be expanded to 6 participants until lowest DL associated with immune response has been expanded. DL1: 10 mcg a-lactalbumin + 10 mcg Zymosan Original DL2:100 mcg a-lactalbumin + 100 mcg Zyomsan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1e: 10 mcg a-lactalbumin + 20 mcg Zymosan DL1f: 20 mcg a-lactalbumin + 10 mcg Zymosan DL1g: 20 mcg a-lactalbumin + 10 mcg Zymosan (if DL1e is too toxic) α-lactalbumin vaccine: α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). DL1: 10 mcg DL Original 2: 100 mcg DL2: 100 mcg DL3: 500 mcg D1b: 50 mcg D1e: 10 mcg D1f: 20 mcg D1g: 20 mcg (D1g will only be utilized if D1c is deemed too toxic) Zymosan: Adjuvant used in vaccine preparation DL1: 10 mcg DL Original 2: 100 mcg DL2: 10 mcg DL3: 10 mcg D1b: 10 mcg D1e: 20 mcg D1f: 20 mcg D1g: 1o mcg (D1g will only be utilized if D1c is deemed too toxic)
Preventative Cohort Lowest Immunologic Dose (LID) of α-lactalbumin Vaccine
NA microgram (mcg)
This outcome measure only applies to Cohort 1b (prevention cohort). This measurement was not achieved as only 4 people were enrolled to this cohort, and per protocol 6 participants must be enrolled to determine a LID.

SECONDARY outcome

Timeframe: Day 84

Population: This outcome measure only applies to Cohort 1c (Standard of Care/pembrolizumab cohort). This measurement was not achieved as only 5 people were enrolled to this cohort, and per protocol 6 participants must be enrolled to determine a LID.

LID of α-lactalbumin vaccine in participants who are receiving adjuvant pembrolizumab following initial TNBC treatment, based on ELISPOT assays to assess the ability to induce a pro-inflammatory T cell response consistent with tumor protection. This assessment will be determined using the ELISPOT assay to determine peripheral blood frequencies of T cells that produce interferon-gamma (IFNγ; type-1) and IL-17 (type-17) in response to recombinant human α-lactalbumin

Outcome measures

Outcome measures
Measure
Treatment α-lactalbumin and Zymosan
n=5 Participants
Participants with TNBC will be treated with successively higher doses of α-lactalbumin and zymosan in a 3+3 trial design. Treatment involves 3 vaccinations every 2 weeks. Participants will be enrolled in 1 of 5 dose levels until the MTD is identified (intra-patient dose escalation not permitted), after which it'll be expanded to 6 participants. Successively lower doses will be expanded to 6 participants until lowest DL associated with immune response has been expanded. DL1: 10 mcg a-lactalbumin + 10 mcg Zymosan Original DL2:100 mcg a-lactalbumin + 100 mcg Zyomsan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1e: 10 mcg a-lactalbumin + 20 mcg Zymosan DL1f: 20 mcg a-lactalbumin + 10 mcg Zymosan DL1g: 20 mcg a-lactalbumin + 10 mcg Zymosan (if DL1e is too toxic) α-lactalbumin vaccine: α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). DL1: 10 mcg DL Original 2: 100 mcg DL2: 100 mcg DL3: 500 mcg D1b: 50 mcg D1e: 10 mcg D1f: 20 mcg D1g: 20 mcg (D1g will only be utilized if D1c is deemed too toxic) Zymosan: Adjuvant used in vaccine preparation DL1: 10 mcg DL Original 2: 100 mcg DL2: 10 mcg DL3: 10 mcg D1b: 10 mcg D1e: 20 mcg D1f: 20 mcg D1g: 1o mcg (D1g will only be utilized if D1c is deemed too toxic)
Pembrolizuman Cohort Lowest Immunologic Dose (LID) of α-lactalbumin Vaccine
NA microgram (mcg)
This outcome measure only applies to Cohort 1c (Standard of Care/pembrolizumab cohort). This measurement was not achieved as only 5 people were enrolled to this cohort, and per protocol 6 participants must be enrolled to determine a LID.

Adverse Events

Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Cohort 1b at Dose Level 1: Preventitive A-lactalbumin (aLa) and Zymosan

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Cohort 1c at Dose Level 1: Standard of Care With A-lactalbumin (aLa) and Zymosan

Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan
n=6 participants at risk
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan
n=5 participants at risk
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1b: 50ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan
n=5 participants at risk
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1e: 10ug aLa and 20ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan
n=1 participants at risk
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 2\*: 100ug aLa and 100ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan
n=6 participants at risk
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 2: 100ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan
n=3 participants at risk
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 3: 500ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1b at Dose Level 1: Preventitive A-lactalbumin (aLa) and Zymosan
n=4 participants at risk
Cohort 1b participants are with a BRCA1.BRCA2, or PALB2 mutation undergoing risk reducing mastectomy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1c at Dose Level 1: Standard of Care With A-lactalbumin (aLa) and Zymosan
n=5 participants at risk
Cohort 1c participants are undergoing chemo immunotherapy for operable TNBC. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Psychiatric disorders
Anxiety
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).

Other adverse events

Other adverse events
Measure
Cohort 1a at Dose Level 1: Treatment α-lactalbumin (aLa) and Zymosan
n=6 participants at risk
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 1b: Treatment α-lactalbumin (aLa) and Zymosan
n=5 participants at risk
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1b: 50ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 1e: Treatment α-lactalbumin (aLa) and Zymosan
n=5 participants at risk
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1e: 10ug aLa and 20ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 2*: Treatment α-lactalbumin (aLa) and Zymosan
n=1 participants at risk
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 2\*: 100ug aLa and 100ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 2: Treatment α-lactalbumin (aLa) and Zymosan
n=6 participants at risk
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 2: 100ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1a at Dose Level 3: Treatment α-lactalbumin (aLa) and Zymosan
n=3 participants at risk
Cohort 1a participants are with operable TNBC who have completed all standard therapy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 3: 500ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1b at Dose Level 1: Preventitive A-lactalbumin (aLa) and Zymosan
n=4 participants at risk
Cohort 1b participants are with a BRCA1.BRCA2, or PALB2 mutation undergoing risk reducing mastectomy. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Cohort 1c at Dose Level 1: Standard of Care With A-lactalbumin (aLa) and Zymosan
n=5 participants at risk
Cohort 1c participants are undergoing chemo immunotherapy for operable TNBC. Participants were administered 3 vaccinations every 2 weeks at Dose Level 1: 10ug aLa and 10ug zymosan α-lactalbumin vaccine (aLa): α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). Zymosan: Adjuvant used in vaccine preparation
Blood and lymphatic system disorders
Anemia
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
25.0%
1/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Investigations
Creatinine Increased
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Gastrointestinal disorders
Diarrhea
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
100.0%
1/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Psychiatric disorders
Anxiety
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
33.3%
1/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Investigations
AST increased
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
25.0%
1/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
33.3%
1/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Investigations
Alanine aminotransferase (ALT) increased
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
33.3%
1/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
25.0%
1/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Investigations
Alkaline phosphatase (ALP) increased
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
33.3%
1/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Skin and subcutaneous tissue disorders
Alopecia
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Eye disorders
Blurred vision
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Reproductive system and breast disorders
Breast Pain
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
50.0%
2/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
40.0%
2/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
General disorders
Chest pain (non- cardiac)
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Nervous system disorders
Concentration impairment
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Gastrointestinal disorders
Constipation
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Nervous system disorders
Dizziness
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Endocrine disorders
Endocrine disorders - Other, specify (Hot Flashes)
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
General disorders
Fatigue
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
40.0%
2/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
50.0%
2/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
General disorders
Fever
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
25.0%
1/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Eye disorders
Floaters
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
General disorders
Flu like symptoms
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
66.7%
2/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
25.0%
1/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
General disorders
General disorders and administration site conditions - Other, specify (Bee sting)
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Nervous system disorders
Headache
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Metabolism and nutrition disorders
Hyperglycemia
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
33.3%
1/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
40.0%
2/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Metabolism and nutrition disorders
Hypernatremia
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Metabolism and nutrition disorders
Hyponatremia
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
General disorders
Injection site reaction
100.0%
6/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
100.0%
5/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
100.0%
5/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
100.0%
1/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
100.0%
6/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
100.0%
3/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
100.0%
4/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
100.0%
5/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify (Right Knee Meniscal Tear)
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Psychiatric disorders
Insomnia
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
25.0%
1/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
33.3%
1/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Blood and lymphatic system disorders
Lymph node pain
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Investigations
Lymphocyte count decreased
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
33.3%
1/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Investigations
Lymphocyte count increased
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
100.0%
1/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
General disorders
Malaise
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify (Toothache)
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
100.0%
1/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
33.3%
2/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Respiratory, thoracic and mediastinal disorders
Nasal congestion
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
General disorders
Nausea
33.3%
2/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
33.3%
1/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Musculoskeletal and connective tissue disorders
Neck Pain
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other, ductal carcinoma in situ
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
25.0%
1/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
100.0%
1/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Skin and subcutaneous tissue disorders
Palmer-plantar erythrodysesthesia syndrome
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
40.0%
2/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Nervous system disorders
Paresthesia
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Respiratory, thoracic and mediastinal disorders
Pneumonia
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Respiratory, thoracic and mediastinal disorders
Postnasal drip
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Respiratory, thoracic and mediastinal disorders
Productive cough
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Skin and subcutaneous tissue disorders
Rash Maculopapular
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
33.3%
1/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Musculoskeletal and connective tissue disorders
Rib Pain
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify (Oral mucositis)
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
16.7%
1/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Infections and infestations
Upper respiratory infection
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
25.0%
1/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Infections and infestations
Urinary tract infection
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Eye disorders
Uveitis
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
Investigations
White blood cell decreased
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/1 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/6 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
33.3%
1/3 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
0.00%
0/4 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).
20.0%
1/5 • All adverse events are reported that occur through 28 days after the final dose of the study drug (up to Day 84).

Additional Information

Principal Investigator, G. Thomas Budd, MD

Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Phone: 216-444-6480

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place