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

NCT06541639 | Recruiting Phase 1 DMC

• 1 other identifier: EVM16CX01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Advanced or Recurrent Solid Tumors

Keywords

solid tumor; tumor vaccine; immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (6)

• immunogenicity of EVM16

  during the intervention, up to 1 year

• objective response rate (ORR) of EVM16 in combination with tislelizumab

  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

  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

  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

  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.

Study Arms (4)

Dose Escalation Level 1

EXPERIMENTAL

EVM16 dose level 1 as single and combined therapy with Tislelizumab.

Biological: EVM16; Drug: Tislelizumab

Dose Escalation Level 2

EXPERIMENTAL

EVM16 dose level 2 as single and combined therapy with Tislelizumab.

Biological: EVM16; Drug: Tislelizumab

Dose Escalation Level 3

EXPERIMENTAL

EVM16 dose level 3 as single and combined therapy with Tislelizumab.

Biological: EVM16; Drug: Tislelizumab

Dose Expansion

EXPERIMENTAL

EVM16 RP2D dose in combination with Tislelizumab.

Biological: EVM16; Drug: Tislelizumab

Interventions

EVM16 BIOLOGICAL

cancer vaccine

Dose Escalation Level 1; Dose Escalation Level 2; Dose Escalation Level 3; Dose Expansion

Tislelizumab DRUG

Anti-PD1 antibody

Also known as: Tevimbra

Dose Escalation Level 1; Dose Escalation Level 2; Dose Escalation Level 3; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Shanghai Cancer Centre: collaborator
• Everest Medicines (China) Co.,Ltd.: collaborator

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200135, China

RECRUITING

MeSH Terms

Interventions

tislelizumab

Study Officials

• Lin Shen, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Shen, MD

CONTACT

+8601088196561; linshenpkn@163.com

Yanshuo Cao, MD

CONTACT

+8601088196561; yanshuo.cao@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beijing Cancer Hospital

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 7, 2024
• Study Start: March 4, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)