EVM14 alone and with pembrolizumab for selected advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, open-label, multiregional Phase I/Phase IIa trial that gives EVM14 intramuscularly either as monotherapy or combined with pembrolizumab. Phase I will enroll monotherapy and combination cohorts to define safety, tolerability, immunogenicity, and preliminary signs of efficacy and to select a dose for Phase IIa. In Phase IIa the selected EVM14 dose will be tested with pembrolizumab to further characterize safety, immune response, and early clinical activity. Eligible participants have pathologically confirmed unresectable, recurrent, or metastatic selected solid tumors with at least one measurable lesion per RECIST v1.1 and ECOG 0–1.

Why it matters

Who can join: the full rules

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).

Where it's running

• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• NEXT Oncology
  Fairfax, Virginia, United States Recruiting
• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting
• Nanjing Drum Tower Hospital
  Nanjing, Jiangsu, China Recruiting
• The First Affiliated Hospital With Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Everest Clinical Trial Information Center
• Email: ctinfo.center@everestmedicines.com
• Phone: +86 21 8012 5712

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.