RecruitingPhase 1Phase 2NCT06530251

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)


Sponsor

Akeso

Enrollment

280 participants

Start Date

Sep 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing AK112 — a new bispecific drug that targets both PD-1 (an immune checkpoint) and VEGF (a protein that promotes tumor blood vessel growth) — in patients with advanced hepatocellular carcinoma (liver cancer) that has progressed or they have not yet received treatment. **You may be eligible if...** - You have confirmed advanced liver cancer (hepatocellular carcinoma, HCC) - You are in good physical condition (ECOG 0 or 1) - You have a life expectancy of at least 3 months - For some parts of the study: your cancer has progressed after prior therapy; for others: you have not yet received systemic treatment **You may NOT be eligible if...** - You have serious liver disease that would make treatment unsafe - You are in poor physical condition - Your liver cancer does not meet imaging or biopsy diagnostic criteria - You have received treatments that exclude you from the specific phase of the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK112

Following a predefined dose and date.

DRUGCadonilimab

Following a predefined dose and date.

DRUGAK127

Following a predefined dose and date.

DRUGAK130

Following a predefined dose and date.

DRUGSintilimab Injection

Following the local label direction.

DRUGBevacizumab biosimilar

Following the local label direction.


Locations(2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)

Jinan, Shandong, China

View Full Details on ClinicalTrials.gov

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NCT06530251


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