This is a phase I/II, single arm, multicenter study of EVER4010001 combination with Pembrolizumab in advanced solid tumor patients. The primary endpoint of phase I will be Dose-limiting toxicities (DLTs) observed in combined administration of EVER4010001 and Pembrolizumab. And the primary endpoint of phase II will be the ORR per RECIST v1.1 in all treated patients.~Patients will be treated until progression requiring discontinuation of further treatment, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor response and progression will be assessed using RECIST v1.1 and assessment by investigator at the trail center will be sufficient for decisions on continuation of treatment. All patients will visit the investigator at regular intervals for assessment of safety parameters and AEs.
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of EVER4010001 in combination with Pembrolizumab in Patients with Advanced Solid Tumors. And in phase II to assess the anti-tumor efficacy of EVER4010001 in combination with Pembrolizumab in treating selected indications using appropriate biomarkers.