EVM16 Injection As a Single and Combination with Tislelizumab in Solid Tumors
NCT ID: NCT06541639
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
78 participants
INTERVENTIONAL
2025-03-04
2028-06-30
Brief Summary
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The main questions to answer are:
Safety of EVM16. Suitable dose of EVM16. Effects of EVM16 combined with tislelizumab.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Level 1
EVM16 dose level 1 as single and combined therapy with Tislelizumab.
EVM16
cancer vaccine
Tislelizumab
Anti-PD1 antibody
Dose Escalation Level 2
EVM16 dose level 2 as single and combined therapy with Tislelizumab.
EVM16
cancer vaccine
Tislelizumab
Anti-PD1 antibody
Dose Escalation Level 3
EVM16 dose level 3 as single and combined therapy with Tislelizumab.
EVM16
cancer vaccine
Tislelizumab
Anti-PD1 antibody
Dose Expansion
EVM16 RP2D dose in combination with Tislelizumab.
EVM16
cancer vaccine
Tislelizumab
Anti-PD1 antibody
Interventions
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EVM16
cancer vaccine
Tislelizumab
Anti-PD1 antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Shanghai Cancer Centre
OTHER
Everest Medicines (China) Co.,Ltd.
INDUSTRY
Peking University
OTHER
Responsible Party
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Shen Lin
Beijing Cancer Hospital
Principal Investigators
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Lin Shen, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EVM16CX01
Identifier Type: -
Identifier Source: org_study_id
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