drugset / Trial / NCT06938321

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

NCT06938321

Phase 1/2 Recruiting 135 enrolled Akeso
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-04-30
Primary completion
2027-05
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivonescimab Monoclonal antibody
Subject LUCORAFUSP ALFA Protein / enzyme biologic

Indications