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A Phase 1a/1b Safety and Tolerability Study of FPT155 in Patients with Advanced Solid Tumors
Five Prime Therapeutics, Inc.
This is an uncontrolled phase 1a/1b dose escalation, exploration and expansion trial. A recommended dose for FPT155 will be identified in the Phase 1a (the dose escalation phase) and will undergo further clinical evaluation in Phase 1b. In Phase 1a, FPT155 will be administered intravenously every three weeks, on the fist day of each 21-day cycle, at 8 different dosing levels (0.07mg, 0.21mg, 0.70mg, 2.1mg, 7.0mg, 21.0mg, 42.0mg and 70.0mg). Patients will be assigned to a dose level based on their order of enrolment and will continue treatment until it is no longer tolerated or their disease has worsened. Key inclusion criteria for patients in Phase 1a only: disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments.