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A Phase III Randomized Controlled Trial to Compare BL-B01D1 With Physician's Choice of Chemotherapy (Last Line) in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Previously Treated With PD-1/PD-L1 Monoclonal Antibody and at Least Two Lines of Chemotherapy (at Least One Line of Platinum-based Chemotherapy)

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Trial Profile

A Phase III Randomized Controlled Trial to Compare BL-B01D1 With Physician's Choice of Chemotherapy (Last Line) in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Previously Treated With PD-1/PD-L1 Monoclonal Antibody and at Least Two Lines of Chemotherapy (at Least One Line of Platinum-based Chemotherapy)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Jun 2026

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At a glance

  • Drugs Izalontamab brengitecan (Primary) ; Capecitabine; Docetaxel; Gemcitabine
  • Indications Carcinoma; Nasopharyngeal cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Sichuan Baili Pharmaceutical

Most Recent Events

  • 22 Jun 2026 According to SystImmune media release, , Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), has received regulatory approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for iza-bren (BL-B01D1) for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed following prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy based on results from this trial.
  • 24 Oct 2025 According to SystImmune media release, results published in The Lancet.
  • 24 Oct 2025 According to SystImmune media release, data presented at the venue of the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin.

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