Shanghai-based biotech company GenFleet Therapeutics announced that two clinical trial applications (CTAs) for its drug candidate GFH018 have been approved in China. GFH018 is a small molecule designed to specifically target and inhibit TGF-ß R1.
Clinical Trial Details
- Trial 1 (GFH018X0201): A Phase Ib/II study assessing GFH018 in combination with a PD-1 inhibitor for advanced solid tumors. This trial is being conducted in Australia and Taiwan, with the dose escalation Ib phase completed and the Phase II dose expansion ongoing.
- Trial 2 (GFH018X0202): A Phase II study evaluating GFH018 paired with a PD-1 inhibitor, immunochemotherapy, and radiotherapy for advanced and unresectable non-small cell lung cancer (NSCLC). The aim is to improve the immunosuppressive microenvironment and reduce side effects from radiotherapy and chemotherapy.
Significance
The TGF-ß signaling pathway is a key target for multiple solid tumors. Despite its importance, no drugs targeting this pathway have been approved globally. GenFleet’s GFH018 could potentially fill this gap, offering new treatment options for patients with advanced cancers.-Fineline Info & Tech
