Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer
This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab.
Primary: To evaluate the safety and tolerability of FLX475 as a single agent and in combination with pembrolizumab in subjects with advanced cancer;
To evaluate the anti-tumor activity of FLX475 as a single agent and in combination with pembrolizumab in subjects with advanced solid tumors.
Secondary: To define the maximum tolerated dose (MTD) and/or RP2D of FLX475, both as a single agent and in combination with pembrolizumab; To evaluate the PK profile of FLX475 alone and in combination with pembrolizumab; To assess the effects of FLX475 alone or in combination with pembrolizumab on PD markers
relating to drug mechanism of action; To explore the relationships of PK and PD parameters to clinical drug activity; To characterize the onset, magnitude, and duration of tumor control in subjects receiving FLX475 alone or in combination with pembrolizumab
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