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| Name | Class |
|---|---|
| Shanghai Cancer Centre | OTHER |
| Everest Medicines (China) Co.,Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Level 1 | Experimental | EVM16 dose level 1 as single and combined therapy with Tislelizumab. |
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| Dose Escalation Level 2 | Experimental | EVM16 dose level 2 as single and combined therapy with Tislelizumab. |
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| Dose Escalation Level 3 | Experimental | EVM16 dose level 3 as single and combined therapy with Tislelizumab. |
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| Dose Expansion | Experimental | EVM16 RP2D dose in combination with Tislelizumab. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVM16 | Biological | cancer vaccine |
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| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability | The incidence and severity of adverse events (AEs) and serious adverse events (SAEs), the incidence of dose-limiting toxicity (DLT) （only in phase Ia）, 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. | From the first study intervention to 90 days after the last study intervention. |
| RP2D for EVM16 | Based on safety, tolerability, immunogenicity to determine RP2D. | During the intervention, up to approximately 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen, MD | Contact | +8601088196561 | linshenpkn@163.com | |
| Yanshuo Cao, MD | Contact | +8601088196561 | yanshuo.cao@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lin Shen, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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A Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity, and Initial Efficacy of EVM16 Injection as a Single and Combination with Tislelizumab in Subjects with Advanced or Recurrent Solid Tumors.
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| Tislelizumab | Drug | Anti-PD1 antibody |
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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. |
| From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first. |
| 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. | From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first. |
| 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. | From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first. |
| 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. | From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first. |
| PFS of EVM16 in combination with tislelizumab （Only in phase Ib） | Progression-free survival (PFS) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm. | From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200135 | China |
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