A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC)

Sponsor
Akeso
Study ID
NCT06530251
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • AK112 — DRUG
    Following a predefined dose and date.
  • Cadonilimab — DRUG
    Following a predefined dose and date.
  • AK127 — DRUG
    Following a predefined dose and date.
  • AK130 — DRUG
    Following a predefined dose and date.
  • Sintilimab Injection — DRUG
    Following the local label direction.
  • Bevacizumab biosimilar — DRUG
    Following the local label direction.

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 AK112 in combination therapies 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 hepatocellular carcinoma (HCC), 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 therapy or monotherapy in the treatment of HCC compared to the combination of Sintilimab and Bevacizumab biosimilar.

Key Dates

First listed
Jul 31, 2024
Start date
Sep 24, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Sep 30, 2028

Study Design

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

Arms

  • Experimental: AK112 in combination with AK130
  • Experimental: AK112 in combination with AK127
  • Experimental: AK112 in combination with Cadonilimab
  • Experimental: AK112
  • Active Comparator: Sintilimab in combination with Bevacizumab biosimilar

Primary Outcome Measure

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

Central Contacts

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