A Study of BLZ945 Single Agent or BLZ945 in Combination With PDR001 in Advanced Solid Tumors
Status:
Active, not recruiting
Trial end date:
2022-03-17
Target enrollment:
Participant gender:
Summary
The purpose of this first-in-human (FIH) study of BLZ945 given as a single agent or in
combination with PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics, and anti-tumor activity of BLZ945, administered orally, as a single agent
or in combination with PDR001, administered intravenously (i.v.) in adult patients with
advanced solid tumors.
Dose escalation will be guided by a Bayesian logistic regression model with overdose control.
Once MTD/ RP2D is declared, glioblastoma patients will be enrolled in the phase II part to
further assess the preliminary anti-tumor activity of BLZ945 as single agent and in
combination with PDR001.