NCT06530251

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

A Phase Ib/II Study of AK112 in Combination Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 280 (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 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.

Conditions

• Hepatocellular Carcinoma

Interventions

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

Timeline

• Start date: 2024-09-24
• Primary completion: 2026-06-01
• Completion: 2028-09-01
• First posted: 2024-07-31
• Last updated: 2026-03-04

Locations

2 sites across 1 country: China