NCT06938321

A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer

An Open Label, Multicenter, Phase Ib/II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

There're 2 parts in this interventional study: 1. The goal of phase Ib trial is to evaluate the safety and tolerability of AK130 in combination with AK112 therapy for the purpose of observing the incidence of dose limit toxicity (DLT) as well as the confirmation of maximum tolerable dose (MTD) in the treatment of advanced biliary tract cancer (BTC), so as to determine the recommended phase 2 dose (RP2D) in the second part of the trial. 2. The goal of phase II trial is to evaluate the safety and efficacy of AK112 in combination with AK130 therapy or monotherapy in the treatment of advanced BTC.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	AK112	Following a predefined dose and date.
DRUG	AK130	Following a predefined dose and date.

Timeline

• Start date: 2025-04-30
• Primary completion: 2027-05-01
• Completion: 2027-12-01
• First posted: 2025-04-22
• Last updated: 2026-03-03

Locations

1 site across 1 country: China