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A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other Solid Tumors

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Trial Profile

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 16 Oct 2025

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At a glance

  • Drugs Izalontamab brengitecan (Primary)
  • Indications Carcinoma; Head and neck cancer; HER2 negative breast cancer; Nasopharyngeal cancer; Non-small cell lung cancer; Oesophageal cancer; Small cell lung cancer; Squamous cell cancer
  • Focus Adverse reactions
  • Sponsors SystImmune

Most Recent Events

  • 18 Aug 2025 According to SystImmune media release, company announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to izalontamab brengitecan for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
  • 22 Jul 2024 Planned End Date changed from 30 Sep 2025 to 21 Mar 2028.
  • 22 Jul 2024 Planned primary completion date changed from 31 Jul 2024 to 31 Dec 2025.

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