Phase 1/2 OBI-902 TROP-2 antibody-drug conjugate trial in advanced solid tumors

This trial is designed to evaluate the safety, pharmacokinetics, and clinical activity of OBI-902 as dose-finding monotherapy in a phase 1 setting and at an optimized dose in phase 2 expansion cohorts. It includes participants with advanced or metastatic solid tumors, such as refractory HER2-negative breast cancer, endometrial carcinoma, and cholangiocarcinoma. OBI-902 is a TROP-2 directed monoclonal antibody-drug conjugate delivering an undisclosed toxin. Sponsored by OBI Pharma, Inc. Given existing TROP-2 ADC benchmarks (e.g., sacituzumab govitecan; in some settings datopotamab deruxtecan), this program probes a distinct linker/payload aiming for efficacy with manageable toxicity.