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

Sponsor
Shanghai Henlius Biotech
Study ID
NCT07358585
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Colon Cancer Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HLX43 dose 1 + HLX07 — DRUG
    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
  • HLX43 dose 2 + HLX07 — DRUG
    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
  • HLX43 dose 3 + Serplulimab — DRUG
    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
  • HLX43 dose 4 + Serplulimab — DRUG
    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

Study Details

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

Key Dates

Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Jul 28, 2027
Completion
Aug 23, 2028

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HLX43 dose 1
    HLX43 dose 1 + HLX07 1000mg, Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
  • Experimental: HLX43 dose 2
    HLX43 dose 2 + HLX07 1000mg, Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
  • Experimental: HLX43 dose 3
    HLX43 dose 3 + Serplulimab 300mg, Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
  • Experimental: HLX43 dose 4
    HLX43 dose 4 + Serplulimab 300mg, Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)

Primary Outcome Measure

ORR [ Time Frame: From enrollment to 12 weeks after last patient in ]

Central Contacts