CStone Pharmaceuticals announced the enrollment of the first patient in a global multicenter Phase 1b clinical trial for CS5001, an anti-ROR1 antibody-drug conjugate (ADC), which is a key asset in their Pipeline 2.0

CS5001 showed encouraging safety and anti-tumor activity in Phase 1a trials, where it was well tolerated by heavily pre-treated patients with advanced B-cell lymphomas and solid tumors, with no dose-limiting toxicity observed up to dose level 10 (DL10)

At the recommended Phase 2 dose (DL8, 125 μg/kg), CS5001 achieved an ORR of 70% in advanced B-cell lymphoma and 100% in Hodgkin lymphoma, with promising efficacy also seen in advanced solid tumors like NSCLC and pancreatic cancer

The Phase 1b trial aims to optimize CS5001’s dosing and expand its use, with plans for a potential Phase 2 registrational trial for relapsed/refractory DLBCL, as well as exploring its use as a monotherapy or in combination with frontline treatments across multiple cancers