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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

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Trial Profile

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 of Trial: Phase I/II

Latest Information Update: 02 Feb 2026

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At a glance

  • Drugs HLX 43 (Primary) ; Pimurutamab (Primary) ; Serplulimab (Primary)
  • Indications Adenocarcinoma; Colorectal cancer; Solid tumours
  • Focus Therapeutic Use
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 02 Feb 2026 New trial record
  • 27 Jan 2026 According to a Henlius Biotech, company announced that the investigational new drug (IND) application for a clinical trial of HLX43, the innovative programmed death-ligand 1 (PD-L1) targeting antibody-drug conjugate (ADC), in combination with the company's anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) and independently developed innovative anti-EGFR mAb HLX07 has been approved by the China National Medical Products Administration (NMPA), for the treatment of advanced solid tumors
  • 27 Jan 2026 According to a Henlius Biotech, the clinical trial application of HLX43 in combination with HLX07 or Serplulimab for the treatment of advanced solid tumors, was approved by the National Medical Products Administration (NMPA) of China.

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