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A Randomized, Double-blind, Multi-center, Phase II Study to Evaluate the Anti-tumor Efficacy, Safety and Tolerability of HLX53 (an Anti-TIGIT Fc Fusion Protein) Combined With Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) Compared to Placebo + Serplulimab + HLX04, in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

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A Randomized, Double-blind, Multi-center, Phase II Study to Evaluate the Anti-tumor Efficacy, Safety and Tolerability of HLX53 (an Anti-TIGIT Fc Fusion Protein) Combined With Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) Compared to Placebo + Serplulimab + HLX04, in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 23 Dec 2024

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At a glance

  • Drugs HLX 53 (Primary) ; Bevacizumab; Serplulimab
  • Indications Liver cancer
  • Focus Therapeutic Use
  • Sponsors Shanghai Henlius Biotech

    • Most Recent Events

    • 08 Aug 2024 Status changed from not yet recruiting to recruiting.
    • 08 Aug 2024 According to a Shanghai Henlius Biotech media release, company announced that the first patient has been dosed in a phase 2 clinical trial (NCT06349980) of HLX53.
    • 17 Apr 2024 According to a Shanghai Henlius Biotech Inc. media release, company announced that investigational new drug application (IND) for the clinical trial of HLX53, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first line treatment of locally advanced or metastatic hepatocellular carcinoma, has been approved by the National Medical Products Administration (NMPA)

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