A Phase 1 Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of BL-M07D1 in Subjects with HER2 Expressing Advanced Malignant Solid Tumors

Brief description of study

This is a multicenter Phase 1 study evaluating the safety, tolerability, pharmacokinetic (PK) profile, and initial efficacy of BL-M07D1 in subjects with metastatic or unresectable HER2-expressing cancers. This study has three parts: dose escalation, dose finding and dose expansion. This study will determine the MTD (if reached), maximum administered dose (MAD), and RDE. The dose and dosing schedule used for this study were based on nonclinical studies and a Phase 1 Study, BL-M07D1-101, conducted in China.


Clinical Study Identifier: s25-00316
ClinicalTrials.gov Identifier: NCT06293898
Principal Investigator: Nancy Chan.
Other Investigators: Marta Wioleta Wronska, Casey E Chambers, Elaine Shum, Yoke Wah Khoo, Kirby Rodriguez, Janice Mehnert, Maya Dimitrova, Mariam M Cheaib, Minas Platon Economides, Allie Nussbaum, Manuel Hidalgo Medina, Joshua K Sabari, Mary K O'Keeffe, Marissa Rybstein, Nina Beri, Rajwanth Veluswamy, Paul E. Oberstein, Eneil De La Pena, Kathleen M Lutz, Maria Francis, Jessica Wang, Salman Rafi Punekar, Michelle Diane Swanson Lightfoot, Paige Gugerty, Jeffrey G Schneider, Anastasiya Apanasyuk, Alexander A Hindenburg, Zujun Li, Keriann M Scavone, Samantha VanMaanen, Bhavana Pothuri, Kristen Spencer, Kathleen M Madden, Michael Shusterman, David R. Wise, Ruth A White, Matthew A. Ingham, Douglas K Marks.


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