New combo therapy aims to shrink Hard-to-Treat tumors
NCT ID NCT07095868
First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times
Summary
This early-stage trial tests a new drug called EVM14, given alone or with an immunotherapy (pembrolizumab), in people with advanced solid tumors that have spread or come back. The main goals are to check safety, find the right dose, and see if the drug helps control the cancer. About 94 participants will be enrolled.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 94 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hunan Cancer Hospital
RECRUITINGChangsha, Hunan, 410006, China
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10022, United States
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NEXT Oncology
RECRUITINGFairfax, Virginia, 22031, United States
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Nanjing Drum Tower Hospital
RECRUITINGNanjing, Jiangsu, 210000, China
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Shanghai Pulmonary Hospital
RECRUITINGShanghai, Shanghai Municipality, 200433, China
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The First Affiliated Hospital With Nanjing Medical University
RECRUITINGNanjing, Jiangsu, 210029, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors
- Can a new drug shield kidneys from chemotherapy damage?
- Mining Responders' tumors for clues to a universal cancer therapy
- Proton boost radiotherapy aims to hit large tumors harder while sparing healthy tissue
- New antibody aims to preserve immune checkpoint while fighting cancer
- Engineered immune cells target two markers on Hard-to-Treat tumors