RecruitingPhase 2NCT06048133

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)

Sponsor

Nataliya Uboha

Enrollment

33 participants

Start Date

Mar 8, 2024

Study Type

INTERVENTIONAL

Conditions

Cholangiocarcinoma Bile Duct Cancer Biliary Tract Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding two experimental immune-boosting drugs (AB680 and AB122) to the standard chemotherapy regimen (gemcitabine plus cisplatin) improves outcomes for patients with advanced bile duct cancer (cholangiocarcinoma or gallbladder cancer) as a first-line treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced (locally advanced, recurrent, or metastatic) biliary tract cancer confirmed by biopsy - You have not yet received systemic treatment for advanced disease - Your performance status is ECOG 0–2 and your organ function is adequate **You may NOT be eligible if...** - You have received prior chemotherapy for advanced biliary tract cancer - You have uncontrolled autoimmune disease or active serious infections - You have significant organ failure - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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