China-based Betta Pharmaceuticals (SHE: 300558) announced that the first subject has been enrolled in a Phase I clinical study of BPI-442096 for advanced solid tumors. The multi-center trial, which includes dosage escalation and expansion phases, will assess the safety, tolerability, and preliminary efficacy of BPI-442096, and determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and the recommended Phase II dose (RP2D).
Mechanism of Action
BPI-442096 inhibits SHP2 activation by targeting the allosteric site of the SHP2 protein, thereby inhibiting signaling pathways such as RAS-MAPK and PD-L1/PD-1. This mechanism disrupts tumor cell proliferation, growth, survival, motility, and metabolism.
Regulatory Approvals
The drug received approval for clinical trials in China in January this year and obtained approval in the US for advanced solid tumors four months later.-Fineline Info & Tech
