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

P

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)

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

Trial contacts and locations

2

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Central trial contact

Lin Shen, MD; Yanshuo Cao, MD

Data sourced from clinicaltrials.gov

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