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

NCT07095868 | Recruiting Phase 1 FDA Drug

• 1 other identifier: EVM14C101
• Study Type: interventional
• Target: 94
• Locations: 2 countries
• Sites: 7

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

Keywords

Solid Tumor; Cancer Vaccine

Outcome Measures

Primary Outcomes (3)

• Phase I and Phase IIa: Incidence and severity of adverse events

  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)

  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)

  The time from date of randomization to the first documented disease progression per RECIST 1.1 evaluated by Investigators or death due to any cause, whichever occurs first.

  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)

Secondary Outcomes (5)

• Phase I and Phase IIa: Objective response rate (ORR)

  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.)

• Phase I and Phase IIa: Disease control rate (DCR)

  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.)

• Phase I and Phase IIa: Duration of response (DOR)

  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.)

• Phase I and Phase IIa tumor type 2: Progression Free Survival (PFS)

  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.)

• Phase IIa: Time to response (TTR)

  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.)

Study Arms (7)

Phase I Dose Escalation in Monotherapy Cohort

EXPERIMENTAL

Biological: EVM14

Phase I Dose Escalation in Combination Therapy Cohort

EXPERIMENTAL

Biological: EVM14; Combination Product: Pembrolizumab

Phase IIa Dose Level A for tumor type 1

EXPERIMENTAL

Biological: EVM14; Combination Product: Pembrolizumab

Phase IIa Dose Level B for tumor type 1

EXPERIMENTAL

Biological: EVM14; Combination Product: Pembrolizumab

Phase IIa Control arm for tumor type 1

ACTIVE COMPARATOR

Combination Product: Pembrolizumab

Phase IIa Combo therapy for tumor type 2

EXPERIMENTAL

Biological: EVM14; Combination Product: Pembrolizumab

Phase IIa Control for tumor type 2

ACTIVE COMPARATOR

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.

Combination Product: Pembrolizumab

Interventions

EVM14 BIOLOGICAL

Cancer Vaccine

Phase I Dose Escalation in Combination Therapy Cohort; Phase I Dose Escalation in Monotherapy Cohort; Phase IIa Combo therapy for tumor type 2; Phase IIa Dose Level A for tumor type 1; Phase IIa Dose Level B for tumor type 1

Pembrolizumab COMBINATION_PRODUCT

Anti-PD1 antibody

Phase I Dose Escalation in Combination Therapy Cohort; Phase IIa Combo therapy for tumor type 2; Phase IIa Control arm for tumor type 1; Phase IIa Control for tumor type 2; Phase IIa Dose Level A for tumor type 1; Phase IIa Dose Level B for tumor type 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Everest Medicines (Beijing) Co., Ltd.: lead

Study Sites (7)

Memorial Sloan Kettering Cancer Center

New York, New York, 10022, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

NEXT Oncology

Fairfax, Virginia, 22031, United States

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

The First Affiliated Hospital With Nanjing Medical University

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

NOT YET RECRUITING

MeSH Terms

Interventions

pembrolizumab

Central Study Contacts

Jueying Li

CONTACT

+8618516574518; jueying.li@everestmedicines.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2031
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

CN (4); US (3)