NCT06349980View on ClinicalTrials.gov

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.

PHASE2RecruitingINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

August 5, 2024

Primary Completion Date

February 10, 2027

Study Completion Date

February 10, 2027

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.

Trial Locations (1)

Unknown

RECRUITING

Zhongshan Hospital, Fudan University, Shanghai

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY