RecruitingPhase 2NCT06349980

A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

A Randomized, Double-blind, Multi-center, Phase II Study to Evaluate the Anti-tumor Efficacy, Safety and Tolerability of HLX53 (an Anti-TIGIT Fc Fusion Protein) Combined with Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) Compared to Placebo + Serplulimab + HLX04, in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.


Sponsor

Shanghai Henlius Biotech

Enrollment

117 participants

Start Date

Aug 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests different combinations of three drugs (HLX10, HLX04, and HLX53 — a PD-1 inhibitor, a VEGF inhibitor, and another targeted therapy) as first-line treatment for people with advanced liver cancer (hepatocellular carcinoma) to find the best dosing and evaluate how well they work together. **You may be eligible if...** - You are 18 or older and have been diagnosed with liver cancer (HCC) - You have not previously received any systemic (whole-body) treatment for liver cancer - Your liver cancer is advanced-stage (BCLC stage C, or stage B that cannot be treated with local procedures) - You have at least one tumor that can be measured on imaging - Your liver function is adequate **You may NOT be eligible if...** - You have already received systemic treatment for liver cancer - Your liver function is too poor - You have active hepatitis with uncontrolled viral replication - You have serious autoimmune disease - You are pregnant or breastfeeding 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

DRUGHLX53 (1000mg)

HLX53 will be administered by IV infusion at a fixed dose of 1000 mg on Day 1 of each 21-day cycle.

DRUGHLX53 (2000mg)

HLX53 will be administered by IV infusion at a fixed dose of 2000 mg on Day 1 of each 21-day cycle.

DRUGHLX10

HLX10 will be administered by IV infusion at a fixed dose of 300 mg on Day 1 of each 21-day cycle.

DRUGHLX04

HLX04 will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.

OTHERPlacebo

Placebo matching HLX53 will be administered by IV infusion on Day 1 of each 21-day cycle.


Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, China

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NCT06349980


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