EVM16 Injection As a Single and Combination with Tislelizumab in Solid Tumors

March 13, 2025 updated by: Shen Lin, Peking University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200135
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Recurrent or metastatic solid tumors that have been histologically or cytologically pathologically confirmed and are not amenable to radical treatment with surgery or local therapy.
  • Patients with advanced or recurrent solid tumors who have failed prior standard therapy.
  • Expected survival period >6 weeks at the time of informed consent.
  • Adequate organ function
  • Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0 to 1.
  • Is willing to provide archival or fresh tumor tissue samples for EVM16 production.
  • Has adequate treatment washout period prior to first study dose.
  • Has at least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria before enrollment.

Key Exclusion Criteria:

  • Primary central nervous system (CNS) malignancies that are symptomatic, untreated, or in need of curative treatment, or subjects with CNS metastases.
  • Uncontrolled co-morbidities.
  • Cerebrovascular event (stroke, transient ischemic attack, etc.) within 4 months prior to the signing of inform consent form.
  • In screening period male QTcF interval >450 ms; Female QTcF interval >470 ms (calculated by the Fridericia formula).
  • Left ventricular ejection fraction (LVEF) < 50% during the screening period.
  • Diagnosis of immunodeficiency, or history or syndrome of active as well as former autoimmune disease with risk of relapse, or a disease requiring systemic steroid hormone or immunosuppressive drug therapy.
  • Subjects with a history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS).
  • Co-infection HBV and HCV.
  • Presence of any active infection requiring systemic therapy.
  • Patients who are still on any other investigational medications treatment at the time of screening.
  • Previous treatment with cell therapy, tumor vaccines, cytokines, or growth factors for cancer control.
  • Patients with prior intolerance to tislelizumab resulting in permanent termination of tislelizumab.
  • History or presence of significant lung disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation Level 1
EVM16 dose level 1 as single and combined therapy with Tislelizumab.
Biological: EVM16
cancer vaccine
Drug: Tislelizumab
Anti-PD1 antibody
Other Names:
  • Tevimbra
Experimental: Dose Escalation Level 2
EVM16 dose level 2 as single and combined therapy with Tislelizumab.
Biological: EVM16
cancer vaccine
Drug: Tislelizumab
Anti-PD1 antibody
Other Names:
  • Tevimbra
Experimental: Dose Escalation Level 3
EVM16 dose level 3 as single and combined therapy with Tislelizumab.
Biological: EVM16
cancer vaccine
Drug: Tislelizumab
Anti-PD1 antibody
Other Names:
  • Tevimbra
Experimental: Dose Expansion
EVM16 RP2D dose in combination with Tislelizumab.
Biological: EVM16
cancer vaccine
Drug: Tislelizumab
Anti-PD1 antibody
Other Names:
  • Tevimbra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety and tolerability
Time Frame: From the first study intervention to 90 days after the last study intervention.
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
Time Frame: During the intervention, up to approximately 1 year.
Based on safety, tolerability, immunogenicity to determine RP2D.
During the intervention, up to approximately 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immunogenicity of EVM16
Time Frame: during the intervention, up to 1 year
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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 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 Frame: 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 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）
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Collaborators

Everest Medicines (China) Co.,Ltd.
Shanghai Cancer Centre

Investigators

  • Principal Investigator: Lin Shen, MD, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVM16CX01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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