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

NCT07358585 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-01-22

No results posted yet for this study

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

Conditions

  • Colon Cancer Adenocarcinoma

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-07-28
Completion
2028-08-23

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07358585 on ClinicalTrials.gov