Drug Profile

Izalontamab brengitecan - Bristol-Myers Squibb

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

Latest Information Update: 19 May 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

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

12 May 2026 Sichuan Baili Pharmaceutical plans a phase III trial for Biliary cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (IV, Infusion) in May 2026 (NCT07582315)
30 Apr 2026 Sichuan Baili Pharmaceutical plans a phase II/III PANKU-Esophagus02 trial for Oesophageal cancer (Combination therapy, Unresectable, First-line therapy, Recurrent, Late-stage disease, Metastatic disease) in China (IV, Infusion) in April 2025 (NCT07554456)
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)

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