Trial Outcomes & Findings for Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors (NCT NCT04266912)

Last Updated: 2025-11-25

Results Overview

A DLT was evaluated according to the NCI CTCAE 5.0 \& defined as: grade 4 neutropenia lasting greater than 7 days or febrile neutropenia, grade 3 thrombocytopenia with bleeding or grade 4 thrombocytopenia lasting greater than 7 days, any treatment related adverse event that in the opinion of the safety monitoring committee exposes participants to unacceptable risk, a delay of more than 4 weeks before receiving the next scheduled study drug due to persisting toxicities attributable to study drugs, grade 3 nausea, vomiting or diarrhea lasting greater than 72 hours with optimal care, grade 3 fatigue lasting greater or equal to 7 days, grade 3 pneumonitis of any duration, any grade 4 immune related toxicities, any other grade 3 or greater non-hematological AE, including infusion-related reactions of any duration, liver enzymes greater than 3 times above the upper limit of normal and concurrent total bilirubin elevation that is greater than 2 times above the upper limit of normal.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

The DLT monitoring time frame was the first 28-days of study participation (Cycle 1).

Results posted on

2025-11-25

Participant Flow

A phase I/II single center study performed at MD Anderson Cancer Center. Patients were eligible if they had (1) advanced solid tumors for hiwch curative measures did not exist or were not longer effective and (2) had actionable mutations in DNA Damage Response (DDR) genes (ARID1A, ATM, ATR, ATRX, BAP1, BARD1, BRCA1/2, BRIP1, CDK12, CHEK2, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCM, MRE11A, MSH2, NBN (NBS1), PALB2, RAD51, RAD51C, RAD51D, SMARCB1, and VHL).

Patients were first enrolled in dose escalation cohorts to determine the recommendated phase 2 dose before enrolling patients into dose expansion cohorts.

Participant milestones

Participant milestones
Measure	Escalation Dose Level 1 Berzosertib 240 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Escalation Dose Level 2 Berzosertib 480 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Expansion Dose Level 2 Berzosertib 480 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle
Overall Study STARTED	7	6	10
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	7	6	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Escalation Dose Level 1 Berzosertib 240 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Escalation Dose Level 2 Berzosertib 480 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Expansion Dose Level 1 Berzosertib 240 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Expansion Dose Level 2 Berzosertib 480 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle
Overall Study Withdrawal by Subject	1	0	0	0
Overall Study Progression	6	6	0	10

Baseline Characteristics

Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escalation Dose Level 1 n=7 Participants Berzosertib 240 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Escalation Dose Level 2 n=6 Participants Berzosertib 480 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Expansion Dose Level 1 Berzosertib 240 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Expansion Dose Level 2 n=10 Participants Berzosertib 480 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=45 Participants	0 Participants n=12929 Participants	—	0 Participants n=4548 Participants	0 Participants n=28448 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=45 Participants	6 Participants n=12929 Participants	—	7 Participants n=4548 Participants	15 Participants n=28448 Participants
Age, Categorical >=65 years	5 Participants n=45 Participants	0 Participants n=12929 Participants	—	3 Participants n=4548 Participants	8 Participants n=28448 Participants
Sex: Female, Male Female	5 Participants n=45 Participants	4 Participants n=12929 Participants	—	3 Participants n=4548 Participants	12 Participants n=28448 Participants
Sex: Female, Male Male	2 Participants n=45 Participants	2 Participants n=12929 Participants	—	7 Participants n=4548 Participants	11 Participants n=28448 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=45 Participants	0 Participants n=12929 Participants	—	3 Participants n=4548 Participants	4 Participants n=28448 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=45 Participants	6 Participants n=12929 Participants	—	7 Participants n=4548 Participants	19 Participants n=28448 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants	0 Participants n=12929 Participants	—	0 Participants n=4548 Participants	0 Participants n=28448 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants	0 Participants n=12929 Participants	—	0 Participants n=4548 Participants	0 Participants n=28448 Participants
Race (NIH/OMB) Asian	1 Participants n=45 Participants	1 Participants n=12929 Participants	—	0 Participants n=4548 Participants	2 Participants n=28448 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants	0 Participants n=12929 Participants	—	0 Participants n=4548 Participants	0 Participants n=28448 Participants
Race (NIH/OMB) Black or African American	0 Participants n=45 Participants	0 Participants n=12929 Participants	—	0 Participants n=4548 Participants	0 Participants n=28448 Participants
Race (NIH/OMB) White	6 Participants n=45 Participants	4 Participants n=12929 Participants	—	10 Participants n=4548 Participants	20 Participants n=28448 Participants
Race (NIH/OMB) More than one race	0 Participants n=45 Participants	0 Participants n=12929 Participants	—	0 Participants n=4548 Participants	0 Participants n=28448 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants	1 Participants n=12929 Participants	—	0 Participants n=4548 Participants	1 Participants n=28448 Participants
Region of Enrollment United States	7 participants n=45 Participants	6 participants n=12929 Participants	—	10 participants n=4548 Participants	23 participants n=28448 Participants

PRIMARY outcome

Timeframe: The DLT monitoring time frame was the first 28-days of study participation (Cycle 1).

Population: To be evaluable for DLT, patients must have received \>75% of the planned dose of the investigational products in the combination during Cycle 1.

Outcome measures

Outcome measures
Measure	Escalation Dose Level 1 n=7 Participants Berzosertib 240 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Escalation Dose Level 2 n=6 Participants Berzosertib 480 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Expansion Dose Level 1 Berzosertib 240 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Expansion Dose Level 2 n=10 Participants Berzosertib 480 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle
Number of Patients With Dose Limiting Toxicities (DLT) as a Measure of Safety Profile to Determine the Recommended Phase 2 Dose (RP2D). DLT	1 Participants	0 Participants	—	0 Participants
Number of Patients With Dose Limiting Toxicities (DLT) as a Measure of Safety Profile to Determine the Recommended Phase 2 Dose (RP2D). Not DLT	5 Participants	6 Participants	—	10 Participants
Number of Patients With Dose Limiting Toxicities (DLT) as a Measure of Safety Profile to Determine the Recommended Phase 2 Dose (RP2D). Not evaluable for DLT	1 Participants	0 Participants	—	0 Participants

Adverse Events

Escalation Dose Level 1

Serious events: 2 serious events

Other events: 7 other events

Deaths: 6 deaths

Escalation Dose Level 2

Serious events: 2 serious events

Other events: 6 other events

Deaths: 4 deaths

Expansion Dose Level 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Expansion Dose Level 2

Serious events: 4 serious events

Other events: 10 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Escalation Dose Level 1 n=7 participants at risk Berzosertib 240 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Escalation Dose Level 2 n=6 participants at risk Berzosertib 480 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Expansion Dose Level 1 Berzosertib 240 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle	Expansion Dose Level 2 n=10 participants at risk Berzosertib 480 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle
Gastrointestinal disorders Diarrhea	14.3% 1/7 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	0.00% 0/6 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	— 0/0 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	0.00% 0/10 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.
Infections and infestations Lung Infection	14.3% 1/7 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	0.00% 0/6 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	— 0/0 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	0.00% 0/10 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.
General disorders Disease Progression	0.00% 0/7 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	16.7% 1/6 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	— 0/0 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	0.00% 0/10 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.
Infections and infestations Small Intestinal obstruction	0.00% 0/7 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	16.7% 1/6 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	— 0/0 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	0.00% 0/10 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	16.7% 1/6 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	— 0/0 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	0.00% 0/10 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.
General disorders Tumor pain	0.00% 0/7 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	16.7% 1/6 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	— 0/0 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	10.0% 1/10 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.
Investigations Aspartate aminotransferase increased	0.00% 0/7 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	0.00% 0/6 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	— 0/0 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	10.0% 1/10 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.
Investigations Alanine aminotransferase increased	0.00% 0/7 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	0.00% 0/6 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	— 0/0 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	10.0% 1/10 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders Nausea	0.00% 0/7 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	0.00% 0/6 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	— 0/0 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	10.0% 1/10 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders Dysphagia	0.00% 0/7 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	0.00% 0/6 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	— 0/0 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	10.0% 1/10 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders Vomiting	0.00% 0/7 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	0.00% 0/6 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	— 0/0 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	10.0% 1/10 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.
Vascular disorders Thromboembolic event	0.00% 0/7 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	0.00% 0/6 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	— 0/0 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.	10.0% 1/10 • Approximately three years and four months, from the time the first patient signed the informed consent, through the treatment period, and up to 90 days after the last administration of the lst dose of study drug. Adverse events (AEs) were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. All adverse events were captured from the time of signing consent through 90 days after the last dose of study drug, until all drug related toxicities have resolved, or 30 days prior to initiating a new anticancer therapy, whichever occurred first.

Other adverse events

Additional Information

Timothy A. Yap

M.D. Anderson Cancer Center

Phone: 713-563-1930

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place