RecruitingPhase 2NCT07106892

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


Sponsor

Shanghai Henlius Biotech

Enrollment

60 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 DaysMax Age: 75 Days

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HLX43, which is an antibody-drug conjugate (a targeted therapy that delivers chemotherapy directly to cancer cells) that works against PD-L1. The trial is for people with advanced colorectal cancer that has progressed after standard treatments. **You may be eligible if:** - You are between 18 and 75 years old - You have advanced colorectal cancer confirmed by biopsy - Your cancer has progressed after at least one standard treatment, or you could not tolerate standard treatment - You have at least one measurable tumor - Your overall health and organ function are adequate **You may NOT be eligible if:** - You have not tried any prior treatments for colorectal cancer - Your tumors cannot be measured on imaging - You have severe organ dysfunction - 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHLX43 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

DRUGHLX43 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

DRUGHLX43 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


Locations(2)

Beijing Cancer Hospital

Beijing, China

Jinan First People's Hospital

Jinan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07106892


Related Trials