Study of Gemcitabine, Cisplatin, Quemliclustat (AB680) and Zimberelimab (AB122) During First-line Treatment of Advanced Biliary Tract Cancers (QUIC)
Summary
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.
Arms & interventions
- DrugGemcitabine
Gemcitabine IV: Day 1, 8, 22, and 29 every 42 days
- DrugCisplatin
Cisplatin IV: Day 1, 8, 22, and 29 every 42 days of Cycles 1-4 only.
- DrugZimberelimab
Zimberelimab IV: Day 1 and 22 every 42 days
- DrugQuemliclustat
Quemliclustat IV: Day 1, 15, 29 every 42 days
Outcome measures
Primary
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
Secondary
Estimate the overall survival (OS)
Time frame: 2 years
Estimate the objective response rate (ORR)
Time frame: 2 years
Estimate the disease control rate (DCR)
Time frame: 2 years
Estimate the duration of response (DOR)
Time frame: 2 years
Evaluate safety of the proposed drug combination.
Time frame: 2 years
Eligibility criteria
Study locations (4)
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
University of Michigan Health System
Ann Arbor, Michigan, 48109
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
University of Wisconsin
Madison, Wisconsin, 53705