FGFR4 Inhibitor EVER4010001 in Combination With PD-1 Inhibitor Pembrolizumab in Patients With Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Solid Tumors
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 o...
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.
Tracking Information
- NCT #
- NCT04699643
- Collaborators
- Medidata Solutions
- Investigators
- Principal Investigator: Jianming Xu Department of Gastrointestinal Oncology, the Fifth Medical Center, Chinese PLA General Hospital
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