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

Peking University

Status and phase: Enrolling; Phase 1

Conditions: Advanced or Recurrent Solid Tumors

Treatments: Biological: EVM16; Drug: Tislelizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06541639

EVM16CX01

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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78 participants in 4 patient groups

Dose Escalation Level 1

Experimental group

Description:

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

Treatment:

Drug: Tislelizumab

Biological: EVM16

Dose Escalation Level 2

Experimental group

Description:

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

Treatment:

Drug: Tislelizumab

Biological: EVM16

Dose Escalation Level 3

Experimental group

Description:

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

Treatment:

Drug: Tislelizumab

Biological: EVM16

Dose Expansion

Experimental group

Description:

EVM16 RP2D dose in combination with Tislelizumab.

Treatment:

Drug: Tislelizumab

Biological: EVM16