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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Administered intravenously (IV) as specified in the treatment arm
Administered IV as specified in the treatment arm
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida, United States
Goshen Health System
Goshen, Indiana, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Norton Cancer Insititute-Downtown
Louisville, Kentucky, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
...and 12 more locations
Percentage of participants with Adverse Events
Time frame: From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
Percentage of participants who experience a Dose Limiting Toxicity
Time frame: From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm)
Serum concentration of AB308
Time frame: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Serum concentration of zimberelimab
Time frame: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with anti-drug antibodies to AB308
Time frame: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with anti-drug antibodies to zimberelimab
Time frame: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with Objective Response
Time frame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 3-5 years)
Duration of Response
Time frame: From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months
Time frame: From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
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