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OncoMatch/Clinical Trials/NCT06938321

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

Is NCT06938321 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including AK112 and AK130 for biliary tract cancer.

Phase 1/2RecruitingAkesoNCT06938321Data as of May 2026

Treatment: AK112 · AK130There'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.

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Extracted eligibility criteria

Cancer type

Cholangiocarcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: systemic therapy — first-line

treatment failure following prior first-line systemic therapy

Cannot have received: immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors

Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors

Lab requirements

Blood counts

adequate organ function

Kidney function

adequate organ function

Liver function

adequate organ function

Has adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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