Bio-Thera Solutions, Ltd. a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase 1 clinical study evaluating BAT8008, an antibody-drug conjugate (ADC) that targets Trop2. The multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors aims to evaluate the safety and tolerability of BAT8008. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumors.
BAT8008 is an antibody-drug conjugate (ADC) targeting Trop2 designed for the treatment of solid tumors. Trop2 (Trophoblast cell-surface antigens 2), also known as TACSTD2, M1S1, GA733-1, EGP-1, is a member of tumor associated calcium signal transduction protein (TACSTD) family, which is related to the regulation of intracellular calcium concentration.
Trop2 is not expressed or has low expression levels in normal human tissues while overexpressed in a variety of solid tumors, especially epithelial tumors including breast cancer, cervical cancer, colorectal cancer, esophageal cancer, gastric cancer, lung cancer, oral squamous cell cancer, ovarian cancer, prostate cancer, pancreatic cancer, thyroid cancer, urinary bladder cancer, uterine cancer, glioma, etc. High expression levels of Trop2 in tumors is correlated with poor prognosis for patients. Trop2 is a validated drug target with one approved drug for the treatment of solid tumors and is a target of high interest for new drug discovery.
BAT8008 was developed by using Bio-Thera
