drugset / Trial / NCT06530251

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

NCT06530251

Phase 1/2 Recruiting 280 enrolled Akeso
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody
Subject Cadonilimab Monoclonal antibody
Subject Ivonescimab Monoclonal antibody
Subject LANCASTOTUG Monoclonal antibody
Subject LUCORAFUSP ALFA Protein / enzyme biologic
Comparator Sintilimab Injection Unknown