NCT07106892

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Days – 75 Days
• Healthy volunteers: Not accepted

Summary

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Colorectal Cancer (CRC)

Detailed description

This study is an open-label phase II clinical study to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with advanced Colorectal Cancer (CRC).In this study, eligible subjects will be randomized at 1:1:1 ratio, and the patients will be administered with HLX43 at different doses via intravenous infusion. After approximately 5 subjects are enrolled in each dose group, enrollment will be suspended. As soon as the efficacy signals and safety data are observed, two dose groups were selected for further exploration in Patients with advanced Colorectal Cancer (CRC).

Conditions

• Colorectal Cancer (CRC)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-12-30
• Completion: 2027-08-30
• First posted: 2025-08-06
• Last updated: 2025-11-17

Locations

2 sites across 1 country: China