NCT07106892View on ClinicalTrials.gov

Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Colorectal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 15, 2025

Primary Completion Date

December 30, 2026

Study Completion Date

August 30, 2027

Conditions
Colorectal Cancer (CRC)
Interventions
DRUG

HLX43 Dose 1;

HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. DOSE 1 is 2.0mg/kg

DRUG

HLX43 Dose 2;

HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. DOSE 2 is 2.5mg/kg

DRUG

HLX43 Dose 3;

HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. DOSE 2 is 3.0mg/kg

Trial Locations (1)

Unknown

Beijing Cancer Hospital, Beijing

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY