NCT07358585

A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer

A Phase Ib/II Study to Evaluate the Efficacy, Safety and Tolerance of HLX43 (an Anti-PD-L1 Antibody Conjugated) Combined With HLX07 (a Recombinant Anti-EGFR Humanized Monoclonal Antibody) or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase Ib/II study to evaluate the efficacy, safety and tolerance of HLX43 combined with HLX07 or Serplulimab in patients with advanced or metastatic colorectal cancer failed or intolerance to standard first-line therapy

Detailed description

This study is a phase Ib/II study to evaluate the efficacy, safety and tolerance of HLX43 (an Anti-PD-L1 antibody conjugated) combined with HLX07 (a recombinant anti-EGFR humanized monoclonal antibody) or Serplulimab in patients with advanced or metastatic colorectal cancer failed or intolerance to standard first-line therapy In this study, eligible subjects will be randomized at 1:1 ratio in 2 different groups in 2 parts (part HLX43 + HLX07 and part HLX43 + Serplulimab) . The patients will be administered with HLX43 at different doses combined with HLX07 or Serplulimab via intravenous infusion.

Conditions

• Colon Cancer Adenocarcinoma

Interventions

Type	Name	Description
DRUG	HLX43 dose 1 + HLX07	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. HLX07 is a recombinant anti-EGFR humanized monoclonal antibody
DRUG	HLX43 dose 2 + HLX07	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. HLX07 is a recombinant anti-EGFR humanized monoclonal antibody
DRUG	HLX43 dose 3 + Serplulimab	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. Serplulimab is an anti-PD-1 humanized monoclonal antibody
DRUG	HLX43 dose 4 + Serplulimab	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. Serplulimab is an anti-PD-1 humanized monoclonal antibody

Timeline

• Start date: 2026-01-31
• Primary completion: 2027-07-28
• Completion: 2028-08-23
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: China