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Izalontamab brengitecan - Bristol-Myers Squibb

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Drug Profile

Izalontamab brengitecan - Bristol-Myers Squibb

Alternative Names: BL-B01D1; BMS-986507; EGFRxHER3 ADC; Iza-bren - Bristol-Myers Squibb

Latest Information Update: 02 Apr 2026

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At a glance

  • Originator Sichuan Baili Pharmaceutical; SystImmune
  • Developer Bristol-Myers Squibb; Sichuan Baili Pharmaceutical; SystImmune
  • Class Antineoplastics; Bispecific antibodies; Drug conjugates; Immunoconjugates
  • Mechanism of Action DNA topoisomerase I inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Nasopharyngeal cancer
  • Phase III Fallopian tube cancer; HER2 negative breast cancer; Non-small cell lung cancer; Ovarian cancer; Peritoneal cancer; Small cell lung cancer; Squamous cell cancer; Triple negative breast cancer; Urogenital cancer
  • Phase II Biliary cancer; Cervical cancer; Colorectal cancer; Endometrial cancer; Gastric cancer; Glioblastoma; Liver cancer; Oesophageal cancer; Renal cancer; Solid tumours
  • No development reported Gastrointestinal cancer

Most Recent Events

  • 30 Mar 2026 Sichuan Baili Pharmaceutical plans a phase III trial for Extensive-stage Small-cell Lung Cancer (Combination therapy, First-line therapy, Late stage disease) in China, in April 2026 (IV, Infusion) (NCT07502300)
  • 26 Feb 2026 Efficacy data from a phase III trial in Triple negative breast cancer released by SystImmune
  • 05 Nov 2025 Phase-II/III clinical trials in Non-small cell lung cancer (Monotherapy, Adjuvant therapy, Metastatic disease, Second-line therapy or greater, Late-stage disease) in Taiwan (unspecified route) (NCT07100080)

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