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

Recruiting now · Phase 1/Phase 2

Conditions studied: Selected Types of Solid Tumor

In brief

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.

Key facts

Study ID: NCT07095868
Run by: Everest Medicines (Beijing) Co., Ltd.
People needed: 94
Starts: 2025-11-17
Expected to finish: 2031-11-01
Last updated by the study team: 2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Selected types of solid tumor that are pathologically confirmed unresectable advanced, recurrent, or metastatic.
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.
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at Screening.
Life expectancy ≥ 3 months.
Patients must have adequate organ function.
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.

You may not qualify if…

Has disease that is suitable for local treatment administered with curative intent.
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.
Histologically/cytologically confirmed nasopharynx cancer. Has non-squamous histology NSCLC. If small cell elements are present, the patient is ineligible.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has a diagnosis of immunodeficiency.
Use of systemic corticosteroid (> 10 mg/day prednisone or equivalent) or other immunosuppressive medication within 14 days before the first dose of study treatment.
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.
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.
Cerebrovascular events (stroke, transient ischemic attack, etc.) within 6 months prior to the first dose of study treatment.
QTcF interval male > 450 msec; female > 470 msec Or serious cardiovascular disease within 6 months prior to the first dose of study treatment
The left ventricular ejection fraction (LVEF) < 50% during the screening period.
History of Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome.
Patients known to be human immunodeficiency virus (HIV)-positive or have acquired immune deficiency syndrome (AIDS).

Where it is running

Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
NEXT Oncology — Fairfax, Virginia, United States (enrolling)
Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (enrolling)
The First Affiliated Hospital With Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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