A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors with FGFR2b Overexpression (FORTITUDE-301)

Solid tumours

Phase 1b: Dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and clinically significant changes in vital signs, visual acuity, and clinical laboratory tests, Phase 2: Objective response (OR) (OR = complete response [CR] + partial response [PR]), measured by computed tomography (CT) or magnetic resonance imaging (MRI) as determined by investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

Phase 1b: Objective response (OR), Phase 1b and 2: Disease control (DC) (CR, PR, or stable disease [SD]), Phase 1b and 2: Time to response (TTR), Phase 1b and 2: Overall survival (OS), Phase 1b: PK parameters for bemarituzumab including, but not limited to, area under the concentration time curve (AUC), maximum observed serum concentration (Cmax), and the observed concentration at the end of a dose interval (Ctrough), Phase 2: PK parameters for bemarituzumab including, but not limited to, AUC, Cmax, and Ctrough, Phase 2: Treatment-emergent adverse events, treatment-related adverse events, and clinically significant changes in vital signs, visual acuity, and clinical laboratory tests, Phase 1b and 2: Duration of response (DOR), Phase 1b and 2: Progression-free survival (PFS)

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