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A Phase I, Multi-Center, Open-Label Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of KF-0210 in Patients With Advanced Solid Tumors
Keythera Pharmaceuticals (Australia) Pty Ltd
This is a dose escalation and expansion trial. In the first (dose escalation) part of this trial, eligible patients will receive oral KF-0210 once daily continuously, until disease progression, intolerance or the patient withdraws from the trial. This part of the trial will be used to determine a recommended phase 2 dose (RP2D). To do this, KF-0210 will be given at an escalating dose (120mg, 240mg, 450mg or 600mg), across 4 cohorts of patients enrolled in this part of the trial. In the second (dose expansion) part of this trial, patients will receive oral KF-0210 at the RP2D in combination with Atezolizumab, which will be administered intravenously, at 1200mg every three weeks.