Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Alone and in Combination in … (NCT07095868) | Clinical Trial Compass
RecruitingPhase 1/2
Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Alone and in Combination in Patients With Selected Solid Tumors
United States, China94 participantsStarted 2025-11-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase I and Phase IIa: Incidence and severity of adverse events
Timeframe: From the the start of the first dose of study treatment to 90 days after the last study treatment or new anti-cancer treatments started, whichever occurs earlier.
2
Phase I: Incidence of dose-limiting toxicities (DLT)
Timeframe: Mono cohort: 28-day period from the first EVM14 monotherapy dose. Combo cohort: Days 1 to 21: 21-day period from the first dose of EVM14 in combination with pembrolizumab.
3
Phase IIa tumor type 1: Progression-free survival (PFS)
Timeframe: From the baseline to disease progression confirmed by radiological examination, the start of a new anti-cancer treatment, withdrawal of informed consent, lost to follow-up, death, or end of study, whichever occurs first. (Up to 3 years)
. 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.