This is a phase 2 study of gemcitabine, cisplatin, zimberelimab (AB122) and quemliclustat (AB680) in subjects with untreated advanced biliary tract cancers (BTC). The study will include a safety run-in involving 6 study participants. The goal of the safety run-in is to screen for early safety signals of the proposed drug combination. Trial enrollment can continue while full safety assessment is being completed for the first 6 subjects. Participants will receive 4 cycles of combination therapy as described. After 4 cycles (\~6 months), cisplatin will be discontinued, while gemcitabine, zimberelimab (AB122), and quemliclustat (AB680) will be continued. Subjects will be treated until disease progression or development of intolerable toxicities. In total, there will be up to 39 participants on the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Gemcitabine IV: Day 1, 8, 22, and 29 every 42 days
Cisplatin IV: Day 1, 8, 22, and 29 every 42 days of Cycles 1-4 only.
Zimberelimab IV: Day 1 and 22 every 42 days
Quemliclustat IV: Day 1, 15, 29 every 42 days
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
University of Wisconsin
Madison, Wisconsin, United States
Estimate the progression free survival (PFS) with gemcitabine, cisplatin, quemliclustat (AB680) and zimberelimab (AB122) in patients with advanced BTCs.
Progression free survival (PFS), as determined by RECIST v1.1, is defined as the time from study registration to the date of documented disease progression or death from any cause.
Time frame: 2 years
Estimate the overall survival (OS)
Overall survival, defined as the time from study enrollment to date of death due to any cause. Subjects without documented death at the time of analysis will be censored at the date of last known contact.
Time frame: 2 years
Estimate the objective response rate (ORR)
Objective response rate, defined as the proportion of subjects with a complete or partial response to treatment according to RECIST, version 1.1.
Time frame: 2 years
Estimate the disease control rate (DCR)
Disease control rate, defined as the proportion of subjects with stable disease, complete or partial response to treatment according to RECIST, version 1.1.
Time frame: 2 years
Estimate the duration of response (DOR)
Duration of Response (DOR) is defined as the time that measurement criteria are met for complete or partial response according to RECIST 1.1 (whichever status is recorded first) until the date recurrent or progressive disease, or death, is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started).
Time frame: 2 years
Evaluate safety of the proposed drug combination.
Safety and tolerability will be assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Time frame: 2 years
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