Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Alone and in Combination in Patients With Selected Solid Tumors
NCT ID: NCT07095868
Last Updated: 2025-11-21
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/PHASE2
94 participants
INTERVENTIONAL
2025-11-17
2031-11-30
Brief Summary
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The purpose of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of EVM14 administered intramuscularly (IM) alone and in combination with pembrolizumab in patients with selected solid tumors.
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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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Phase I Dose Escalation in Monotherapy Cohort
EVM14
Cancer Vaccine
Phase I Dose Escalation in Combination Therapy Cohort
EVM14
Cancer Vaccine
Pembrolizumab
Anti-PD1 antibody
Phase IIa Dose Level A for tumor type 1
EVM14
Cancer Vaccine
Pembrolizumab
Anti-PD1 antibody
Phase IIa Dose Level B for tumor type 1
EVM14
Cancer Vaccine
Pembrolizumab
Anti-PD1 antibody
Phase IIa Control arm for tumor type 1
Pembrolizumab
Anti-PD1 antibody
Phase IIa Combo therapy for tumor type 2
EVM14
Cancer Vaccine
Pembrolizumab
Anti-PD1 antibody
Phase IIa Control for tumor type 2
For patients with tumor type 2, pembrolizumab 200 mg alone will be administered intravenously (IV infusion) every 3 weeks (Q3W) if disease progression doesn't occur.
Pembrolizumab
Anti-PD1 antibody
Interventions
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EVM14
Cancer Vaccine
Pembrolizumab
Anti-PD1 antibody
Eligibility Criteria
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Inclusion Criteria
2. Patients with at least 1 evaluable lesion assessed by Investigators within 28 days prior to the first dose of study treatment as defined per RECIST v1.1.
3. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at Screening.
4. Life expectancy ≥ 3 months.
5. Patients must have adequate organ function.
6. At screening, patients must agree to provide, if available, tumor tissue for biomarker analysis. When archival tumor tissue is not available, it is optional for the patient to undergo a fresh biopsy to collect tumor tissue if deemed medically safe by the Investigator.
Exclusion Criteria
2. Has a diagnosed and/or treated additional malignancy within 5 years prior to the first dose of study treatment except for: curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, and curatively resected in situ breast, cervical cancer, and prostate cancer.
3. Histologically/cytologically confirmed nasopharynx cancer. Has non-squamous histology NSCLC. If small cell elements are present, the patient is ineligible.
4. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
5. Has a diagnosis of immunodeficiency.
6. Use of systemic corticosteroid (\> 10 mg/day prednisone or equivalent) or other immunosuppressive medication within 14 days before the first dose of study treatment.
7. Has active autoimmune disease that has required systemic treatment in past 2 years or history of autoimmune disease that has possibility of relapse or at risk of having these conditions.
8. Poorly controlled co-morbidity, including but not limited to poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) and poorly controlled type 2 diabetes, or other serious conditions requiring systemic treatment. Active gastric or duodenal ulcer.
9. Cerebrovascular events (stroke, transient ischemic attack, etc.) within 6 months prior to the first dose of study treatment.
10. QTcF interval male \> 450 msec; female \> 470 msec Or serious cardiovascular disease within 6 months prior to the first dose of study treatment
11. The left ventricular ejection fraction (LVEF) \< 50% during the screening period.
12. History of Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome.
13. Patients known to be human immunodeficiency virus (HIV)-positive or have acquired immune deficiency syndrome (AIDS).
18 Years
ALL
No
Sponsors
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Everest Medicines (Beijing) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
Fairfax, Virginia, United States
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital With Nanjing Medical University
Nanjing, Jiangsu, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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EVM14C101
Identifier Type: -
Identifier Source: org_study_id
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