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A Multicenter, Open-label, Phase Ib/II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Subjects With Advanced Solid Tumors or AK104 in Combination With Oxaliplatin and Capecitabine As First-line Therapy in Subjects With Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Trial Profile

A Multicenter, Open-label, Phase Ib/II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Subjects With Advanced Solid Tumors or AK104 in Combination With Oxaliplatin and Capecitabine As First-line Therapy in Subjects With Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 02 Jan 2025

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At a glance

  • Drugs Cadonilimab (Primary) ; Capecitabine; Oxaliplatin
  • Indications Adenocarcinoma; Cervical cancer; Gastric cancer; Liver cancer; Oesophageal cancer; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms COMPASSION-03
  • Sponsors Akeso Biopharma

Most Recent Events

  • 31 Jul 2024 Status changed from active, no longer recruiting to completed.
  • 01 Jul 2024 Primary endpoint (Anti-tumor activitiy of AK104 using objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator (Phase II)) has been met, according to the results published in the Nature Medicine.
  • 01 Jul 2024 Results (n=98, data cut-off- 12 July 2023) assessing the safety and efficacy of Cadonilimab plus chemotherapy as first-line treatment in HER2 negative unresectable advanced or metastatic gastric or GEJ adenocarcinoma, published in the Nature Medicine

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