Recruiting
Phase 1
Phase 2

EVM14 & Pembrolizumab

Sponsor:

Everest Medicines (Beijing) Co., Ltd.

Code:

NCT07095868

Conditions

Selected Types of Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EVM14

Pembrolizumab

Study Details

Brief 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.

Conditions

Selected Types of Solid Tumor

Study ID

NCT07095868

Start date

Nov 17, 2025

Status verified date

May, 2026

Completion date

Nov, 2031

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

94 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase I Dose Escalation in Monotherapy Cohort

experimental: Phase I Dose Escalation in Combination Therapy Cohort

experimental: Phase IIa Dose Level A for tumor type 1

experimental: Phase IIa Dose Level B for tumor type 1

active comparator: Phase IIa Control arm for tumor type 1

experimental: Phase IIa Combo therapy for tumor type 2

active comparator: 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.

Interventions

EVM14

Cancer Vaccine

Pembrolizumab

Anti-PD1 antibody

Primary outcome measure

  • Phase I and Phase IIa: Incidence and severity of adverse events [ Time Frame: 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. ]
  • Phase I: Incidence of dose-limiting toxicities (DLT) [ Time Frame: 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. ]
  • Phase IIa tumor type 1: Progression-free survival (PFS) [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Everest Clinical Trial Information Center

+86 21 8012 5712ctinfo.center@everestmedicines.com

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10022

Contacts

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

NEXT Oncology

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Everest Medicines (Beijing) Co., Ltd.

Last update posted

Aug 4, 2026

Last verified

May, 2026

Keywords

  • Solid Tumor
  • Cancer Vaccine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Everest Medicines (Beijing) Co., Ltd. on 2026-08-04.