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

NCT06530251 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-03-04

No results posted yet for this study

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

Interventions

DRUG

Sintilimab Injection

Following the local label direction.

DRUG

Bevacizumab biosimilar

Following the local label direction.

DRUG

AK130

Following a predefined dose and date.

DRUG

AK127

Following a predefined dose and date.

DRUG

AK112

Following a predefined dose and date.

DRUG

Cadonilimab

Following a predefined dose and date.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-24
Primary Completion
2026-06-30
Completion
2028-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06530251 on ClinicalTrials.gov