A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Solid Tumors
Everest Medicines (Beijing) Co., Ltd.
Summary
Brief Summary: The purpose of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of EVM14 administered intramuscularly (IM) alone and in combination with pembrolizumab in patients with selected solid tumors.
Description
EVM14C101 study is a First in Human(FIH), open-label, multiregional, multicenter study conducted in 2 Phases: Phase I and Phase IIa. In Phase I, EVM14 will be administered intramuscularly(IM) as a monotherapy (Mono Cohort) and in combination with pembrolizumab (Combo Cohort) in patients with solid tumors to assess the safety and tolerability, immunogenicity, preliminary efficacy of EVM14 as monotherapy and in combination with pembrolizumab. Based on the safety and immunogenicity data of Phase I, dose of EVM14 will be selected for the Phase IIa. In Phase IIa, the safety and tolerability, prelim…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Selected types of solid tumor that are pathologically confirmed unresectable advanced, recurrent, or metastatic. 2. Patients with at least 1 evaluable lesion assessed by Investigators within 28 days prior to the first dose of study treatment as defined per RECIST v1.1. 3. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at Screening. 4. Life expectancy ≥ 3 months. 5. Patients must have adequate organ function. 6. At screening, patients must agree to provide, if available, tumor tissue for biomarker analysis. When archival tumor tissue is not availa…
Interventions
- BiologicalEVM14
Cancer Vaccine
- Combination ProductPembrolizumab
Anti-PD1 antibody
Locations (7)
- Memorial Sloan Kettering Cancer CenterNew York, New York
- MD Anderson Cancer CenterHouston, Texas
- NEXT OncologyFairfax, Virginia
- Hunan Cancer HospitalChangsha, Hunan
- Nanjing Drum Tower HospitalNanjing, Jiangsu
- The First Affiliated Hospital With Nanjing Medical UniversityNanjing, Jiangsu