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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

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Trial Profile

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 13 Oct 2025

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At a glance

  • Drugs Izalontamab brengitecan (Primary)
  • Indications Head and neck cancer; Nasopharyngeal cancer; Non-small cell lung cancer; Small cell lung cancer; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; First in man
  • Sponsors Sichuan Baili Pharmaceutical

Most Recent Events

  • 26 Sep 2025 Planned End Date changed from 1 Dec 2025 to 1 Dec 2027.
  • 26 Sep 2025 Planned primary completion date changed from 1 Dec 2025 to 1 Dec 2026.
  • 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.

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