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Clinical Trials in China / NCT07095868
Recruiting Phase 1/2

Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Alone and in Combination in Patients With Selected Solid Tumors

NCT07095868 · tracked via the Priya Life Science China tracker
Sponsor
Everest Medicines (Beijing) Co., Ltd.
Phase
Phase 1/2
Started
2025-11-17
Last updated
2026-08-04

Condition(s) studied

Selected Types of Solid Tumor

Investigational drug(s) / intervention(s)

EVM14Pembrolizumab

EVM14: Cancer Vaccine

Pembrolizumab: Anti-PD1 antibody

Study summary

Brief Summary:

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Selected types of solid tumor that are pathologically confirmed unresectable advanced, recurrent, or metastatic. 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: 1. Has disease that is suitable for local treatment administered with curative intent. 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).

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Memorial Sloan Kettering Cancer Center New York New York Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
NEXT Oncology Fairfax Virginia Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Nanjing Drum Tower Hospital Nanjing Jiangsu Recruiting
The First Affiliated Hospital With Nanjing Medical University Nanjing Jiangsu Recruiting
Shanghai Pulmonary Hospital Shanghai Shanghai Municipality Recruiting

On this site

📄 Keytruda (pembrolizumab) drug profile →
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07095868 on ClinicalTrials.gov ↗ ← All trials in China