Status:
COMPLETED
A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies
Lead Sponsor:
Arcus Biosciences, Inc.
Collaborating Sponsors:
Gilead Sciences
Conditions:
Advanced Solid Tumor
Non Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 AB30...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2025
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04772989
Start Date
March 19 2021
End Date
August 25 2025
Last Update
August 28 2025
Active Locations (22)
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1
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States, 90095
2
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida, United States, 32224
3
Goshen Health System
Goshen, Indiana, United States, 46526
4
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242