China-based Bio-Thera Solutions, Ltd. (SHA: 688177) has announced the first patient dosing in a multi-center, open, Phase I clinical study to assess the safety, tolerability, and preliminary efficacy of BAT8007, an antibody-drug conjugate (ADC) targeting Nectin-4. The study’s primary indication is general advanced solid tumors, with the goal of determining the recommended Phase 2 dose (RP2D).
BAT8007 Development and Mechanism
As a Nectin-4-targeted ADC, BAT8007 is designed for the treatment of solid tumors. Nectin-4 is a tumor-associated antigen that is highly expressed on various cancer cells and plays roles in tumor development and propagation, including cellular proliferation, motility, and invasion. BAT8007 was developed using Bio-Thera’s proprietary ADC linker-payload technology, which includes a cleavable but systemically stable linker, a small molecule topoisomerase I inhibitor, and high DAR.
Pre-Clinical Findings
In both in vitro and in vivo pharmacological studies, BAT8007 has demonstrated high anti-tumor activity, good stability, and safety. These promising results support the advancement of BAT8007 into clinical trials, where it will be further evaluated for its potential as a treatment for advanced solid tumors.
Significance of the Clinical Trial
The initiation of the Phase I clinical trial marks a significant milestone in the development of BAT8007. This trial will provide crucial data on the drug’s safety and efficacy, paving the way for further development and potentially expanding treatment options for patients with advanced solid tumors.-Fineline Info & Tech
