Actively Recruiting
Phase IbII Study of AK130 and AK112 Combination Therapy for Advanced Biliary Tract Cancer
Led by Akeso · Updated on 2026-03-03
135
Participants Needed
1
Research Sites
30 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating AK130 combined with AK112 therapy to treat advanced biliary tract cancer BTC in this phase IbII clinical trial sponsored by Akeso. The study aims to determine the safe dose levels in phase Ib by observing dose limiting toxicities and to evaluate the safety and efficacy of these treatments in phase II. This research focuses on patients with advanced or metastatic BTC who have not responded to prior first-line treatments. The study includes two experimental treatment groups one receiving AK112 with AK130 and the other receiving AK112 alone. Both drugs are given following predefined doses and schedules. The first phase assesses safety and tolerability to establish the recommended dose for phase II. The second phase then evaluates treatment effectiveness and safety over approximately two years. Participants will be monitored closely with regular assessments including safety evaluations from the time of consent through 30 days after treatment ends. Researchers will measure treatment responses, disease control, duration of response, time to response, progression-free survival, and overall survival. The study duration averages two years, during which participants undergo laboratory tests, imaging, and clinical exams to evaluate the treatments and monitor side effects.
CONDITIONS
Brief Title
A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer
Research Team
W
Wenting Li
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