A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)
Recruiting now · Phase 1
Conditions studied: Metastatic Neoplasm
In brief
MK-8294, the study medicine, is a type of targeted therapy designed to treat certain solid tumors. The main goals of this study are to learn about the safety of MK-8294 and if people can tolerate it and find the highest dose level of MK-8294 that people can tolerate.
Key facts
- Study ID
- NCT07030712
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 67
- Starts
- 2025-07-23
- Expected to finish
- 2029-07-01
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The main inclusion criteria include but are not limited to the following:
- Has histologically or cytologically confirmed advanced/metastatic solid tumor; including head and neck squamous cell carcinoma, cervical squamous cell carcinoma, esophageal squamous cell carcinoma, breast cancer (triple negative breast cancer, Estrogen Receptor [ER]/progesterone receptor +, human epidermal growth factor receptor 2 negative [HER2-]), endometrial, and bladder cancer by pathology report and have previously failed standard treatment, lack standard treatment options, or are intolerant to standard treatment
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
You may not qualify if…
- The main exclusion criteria include but are not limited to the following:
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has a history of New York Heart Association Class II or greater heart failure
- Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE) (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
- Has ongoing radiation-related toxicities, requiring corticosteroids
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
- Has active infection requiring systemic therapy
- Has history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or have ongoing surgical complications
Where it is running
- Northwestern University ( Site 0101) — Chicago, Illinois, United States (enrolling)
- Houston Methodist Hospital ( Site 0103) — Houston, Texas, United States (enrolling)
- Rambam Health Care Campus ( Site 0201) — Haifa, Israel (enrolling)
- Sheba Medical Center ( Site 0200) — Ramat Gan, Israel (enrolling)
- Radboudumc ( Site 0301) — Nijmegen, Gelderland, Netherlands (enrolling)
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0300) — Amsterdam, North Holland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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