Status:
RECRUITING
EVM16 Injection As a Single and Combination with Tislelizumab in Solid Tumors
Lead Sponsor:
Peking University
Collaborating Sponsors:
Shanghai Cancer Centre
Everest Medicines (China) Co.,Ltd.
Conditions:
Advanced or Recurrent Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 inc...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06541639
Start Date
March 4 2025
End Date
June 30 2028
Last Update
March 18 2025
Active Locations (2)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200135