EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors
NCT Number: NCT06541639
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Advanced or Recurrent Solid Tumors
Interventions: BIOLOGICAL: EVM16|DRUG: Tislelizumab
Sponsor: Peking University
Collaborators: Everest Medicines (China) Co.,Ltd.|Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2028-06-30

Summary:
The goal of this clinical trial is to learn the side effects, safety and effect of a tumor vaccine (EVM16) alone or in combined with an anti-PD-1 antibody (tislelizumab) . This clinical trial will include solid tumor patients who failed standard treatment.

The main questions to answer are:

Safety of EVM16. Suitable dose of EVM16. Effects of EVM16 combined with tislelizumab.

Primary Outcome Measures: safety and tolerability, The incidence and severity of adverse events (AEs) and serious adverse events (SAEs), the incidence of dose-limiting toxicity (DLT), and the incidence of AEs of grade 3 or higher were assessed according to the NCI CTCAE v5.0 in the treatment of EVM16 alone as well as EVM16 in combination with Tislelizumab., during the intervention, up to 1 year|RP2D for EVM16, Based on safety, tolerability, immunogenicity to determine RP2D., during the intervention, up to 1 year
Secondary Outcome Measures: immunogenicity of EVM16, Based on proportion of IFN-γ-positive T cells and/or T cell receptor sequences after EVM16 administration to assess the immunogenicity of EVM16 in subjects with advanced or recurrent solid tumours., during the intervention, up to 1 year|objective response rate (ORR) of EVM16 in combination with tislelizumab, Proportion of patients with partial response (PR) and complete response (CR) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm., Evaluation at baseline and 7 weeks after first dose of treatment, then every 9 weeks up to 1 year.|disease control rate (DCR) of EVM16 in combination with tislelizumab, Proportion of patients with partial response (PR) , complete response (CR) and stable disease (SD) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm., Evaluation at baseline and 7 weeks after first dose of treatment, then every 9 weeks up to 1 year.|duration of disease remission (DOR) of EVM16 in combination with tislelizumab, Duration of objective response (PR and CR) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm., Evaluation at baseline and 7 weeks after first dose of treatment, then every 9 weeks up to 1 year.|time to remission (TTR) of EVM16 in combination with tislelizumab, Time from enrollment to objective response (PR and CR) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm., Evaluation at baseline and 7 weeks after first dose of treatment, then every 9 weeks up to 1 year.|PFS of EVM16 in combination with tislelizumab, Progression-free survival (PFS) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm., Up to 1 year.