Study design
toxicity, toxicities, DLTs
DISEASE, SECONDARY, SOLID TUMORS
This was a Phase 1/2, multicenter, open‐label study conducted at over 33 study sites (3 sites for Phase 1) across China, in patients with advanced solid tumors for the Phase 1 dose escalation component (the focus of this manuscript), followed by a Phase 2 indication expansion part (ongoing). The primary study objective for the Phase 1 part was to determine the MTD and RP2D of EVER4010001 in combination with pembrolizumab. The secondary objectives were to characterize the PK and individual drug exposure, assess anti‐tumor efficacy, safety, and tolerability of EVER4010001 with pembrolizumab, and explore predictive biomarkers.In the Phase 1 part, EVER4010001 was administered orally at a starting dose of 40 mg BID, with pembrolizumab 200 mg administered via intravenous infusion on Day 1 of each 21‐Day treatment cycle (Q3W). After a screening period of up to 28 days, eligible patients received treatment according to a standard “3+3” dose escalation design. Depending on the occurrence of dose‐limiting toxicities (DLTs), 3–6 patients were enrolled at each dose level (EVER4010001 40, 60, 80, or 100 mg BID plus pembrolizumab 200 mg Q3W). Treatment continued until unacceptable toxicity, progressive disease, and/or at the discretion of the Investigator or patient's withdrawal of consent.