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BL-M05D1

DRUG3 trials

Sponsors

Sichuan Baili Pharmaceutical Co., Ltd., SystImmune Inc.

Conditions

Advanced Pancreatic Ductal AdenocarcinomaBiliary Tract CancerEsophageal AdenocarcinomaGastric AdenocarcinomaGastric CancerGastroesophageal Junction AdenocarcinomaLocally Advanced or Metastatic Solid TumorsOther Solid Tumors

Phase 1

A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors
RecruitingNCT06349811
Sichuan Baili Pharmaceutical Co., Ltd.Locally Advanced or Metastatic Solid Tumors
Start: 2024-04-19End: 2026-05-31Target: 30Updated: 2025-06-15
Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors
Active, not recruitingNCT07021066
SystImmune Inc.Advanced Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer, Esophageal Adenocarcinoma +2
Start: 2025-07-30End: 2027-05-31Target: 160Updated: 2026-08-05

Phase 3

A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment
RecruitingNCT07518147
Sichuan Baili Pharmaceutical Co., Ltd.Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Start: 2026-05-15End: 2029-12-01Target: 438Updated: 2026-07-08

Related Papers

Phase I study of BL-M05D1, a novel Claudin18.2-directed antibody-drug conjugate (ADC), in patients with locally advanced or metastatic Claudin18.2–expressing solid tumors.
Journal of Clinical Oncology2026-05-27