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

Sponsor
Akeso
Study ID
NCT06938321
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AK112 — DRUG
    Following a predefined dose and date.
  • AK130 — DRUG
    Following a predefined dose and date.

Study Details

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.

Key Dates

First listed
Apr 22, 2025
Start date
Apr 30, 2025
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AK112 in combination with AK130
  • Experimental: AK112

Primary Outcome Measure

Number of subjects with dose limiting toxicities (DLTs) [ Time Frame: During the first three weeks. ]

Central Contacts

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