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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.

NCT06349980 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2024-12-18

No results posted yet for this study

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.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

HLX53 (1000mg)

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

DRUG

HLX53 (2000mg)

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

DRUG

HLX10

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

DRUG

HLX04

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

OTHER

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Jia Fan · Fudan University

  • Huichuan Sun, Dr · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-05
Primary Completion
2027-02-10
Completion
2027-02-10

Countries

  • China

Study Locations

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Entities

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 NCT06349980 on ClinicalTrials.gov