Biostar Pharma Doses First Patient in Pivotal US Trial of Utidelone for HER2-Negative Breast Cancer Brain Metastases

Reuters2025-12-16

Biostar Pharma Doses First Patient in Pivotal US Trial of Utidelone for HER2-Negative Breast Cancer Brain Metastases

Beijing Biostar Pharmaceuticals Co. Ltd. announced the dosing of the first patient in a pivotal U.S. clinical trial (NCT06764940) evaluating Utidelone Injection (UTD1) in combination with capecitabine for the treatment of HER2-negative breast cancer brain metastases (BCBM). The study, involving approximately 120 subjects across nearly 20 clinical centers in the United States, uses a two-stage design with the primary endpoint of central nervous system objective response rate (CNS-ORR). Previous clinical results with utidelone in combination therapies for HER2-negative BCBM have been presented, including a Phase II study reported at the 2025 ASCO Annual Meeting and another published in JAMA Oncology in 2025, demonstrating CNS-ORR rates of 67.6% and 42.6%, respectively. The U.S. FDA has granted Utidelone orphan drug designation for the treatment of breast cancer brain metastases.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Beijing Biostar Pharmaceuticals Co. Ltd. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN48350) on December 16, 2025, and is solely responsible for the information contained therein.

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