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.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Gemcitabine

  Gemcitabine IV: Day 1, 8, 22, and 29 every 42 days

• Drug
  Cisplatin

  Cisplatin IV: Day 1, 8, 22, and 29 every 42 days of Cycles 1-4 only.

• Drug
  Zimberelimab

  Zimberelimab IV: Day 1 and 22 every 42 days

• Drug
  Quemliclustat

  Quemliclustat IV: Day 1, 15, 29 every 42 days

Locations (4)