Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07095868

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

Led by Everest Medicines (Beijing) Co., Ltd. · Updated on 2025-11-21

94

Participants Needed

7

Research Sites

310 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a selected type of solid tumor that is pathologically confirmed as unresectable advanced, recurrent, or metastatic
  • Have at least one tumor lesion that can be evaluated by investigators within 28 days before starting treatment
  • Have an ECOG performance status of 0 or 1 at screening
  • Have a life expectancy of at least 3 months
  • Have adequate organ function
  • Agree to provide tumor tissue for biomarker analysis if available; fresh biopsy is optional if archival tissue is not available and considered safe by the investigator
Not Eligible

You will not qualify if you...

  • Have a disease suitable for local treatment with curative intent
  • Have had another malignancy diagnosed and/or treated within 5 years before starting treatment, except certain treated skin, bladder, breast, cervical, or prostate cancers
  • Have nasopharynx cancer or non-squamous non-small cell lung cancer; presence of small cell elements excludes participation
  • Have known active central nervous system metastases or carcinomatous meningitis
  • Have a diagnosis of immunodeficiency
  • Have used systemic corticosteroids over 10 mg/day prednisone or equivalent or other immunosuppressive drugs within 14 days before treatment
  • Have active autoimmune disease requiring systemic treatment in the past 2 years or history of autoimmune disease with risk of relapse
  • Have poorly controlled health conditions such as hypertension, type 2 diabetes, or active gastric or duodenal ulcers
  • Have had cerebrovascular events within 6 months before treatment
  • Have prolonged QTcF interval or serious cardiovascular disease within 6 months before treatment
  • Have a left ventricular ejection fraction under 50% during screening
  • Have a history of Stevens-Johnson syndrome or toxic epidermal necrolysis
  • Are known to be HIV-positive or have AIDS

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10022

Actively Recruiting

2

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Not Yet Recruiting

3

NEXT Oncology

Fairfax, Virginia, United States, 22031

Actively Recruiting

4

Hunan Cancer Hospital

Changsha, Hunan, China, 410006

Not Yet Recruiting

5

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China, 210000

Not Yet Recruiting

6

The First Affiliated Hospital With Nanjing Medical University

Nanjing, Jiangsu, China, 210029

Not Yet Recruiting

7

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China, 200030

Not Yet Recruiting

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Research Team

J

Jueying Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

7

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