Sponsor: Fujifilm Manufacturing, Inc.
Sponsor Study ID: FF10832-PEM-201
Study Title: A Phase 2a Study with Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination with Pembrolizumab in Patients with Advanced Solid Tumors
CTO #: 103923
NCT Number: NCT05318573
Phase: II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Bladder, Lung
Study Objectives: To confirm a recommended phase 2 dose (RP2D) of FF-10832 (Gemcitabine Liposome Injection) given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab given intravenously Day 1 of the same 21-day cycle, for treatment of advanced solid tumors; To obtain a preliminary estimate of efficacy of FF-10832 monotherapy in expansion cohorts of patients with urothelial cancer (UC) and on-small cell lung cancer (NSCLC);To obtain a preliminary estimate of efficacy of the combination in expansion cohorts of patients with UC and NSCLC.