A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies (NCT04772989) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies
United States94 participantsStarted 2021-03-19
Plain-language summary
This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Male or female participants ≥ 18 years of age (or age ≥ regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Adequate organ and marrow function
Exclusion Criteria:
* History of trauma or major surgery within 28 days prior to the first dose of study treatment.
* Prior treatment with an anti-TIGIT antibody.
* Any active or prior autoimmune disease that required treatment within 3 years of the first dose of study treatment.
* Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic agents, or use of other investigational drugs within 28 days before first dose of study treatment.
* Discontinued prior immunotherapy for immune related adverse events with a high severity.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
What they're measuring
1
Percentage of participants with Adverse Events
Timeframe: From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
2
Percentage of participants who experience a Dose Limiting Toxicity
Timeframe: From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm)