NCT06048133

Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)

Study of Gemcitabine, Cisplatin, Quemliclustat (AB680) and Zimberelimab (AB122) During First-line Treatment of Advanced Biliary Tract Cancers (QUIC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Nataliya Uboha · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Carcinoma
• Cholangiocarcinoma
• Bile Duct Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-08
• Primary completion: 2026-01-01
• Completion: 2027-07-01
• First posted: 2023-09-21
• Last updated: 2026-01-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study