A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)
A Phase 1 Open-label Study to Evaluate the Safety and Efficacy of MK-8294 Monotherapy in Advanced Solid Tumors
Merck Sharp & Dohme LLC
67 participants
Jul 23, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria10
- 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
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Interventions
30 µg via intravenous (IV) infusion
100 µg via intravenous (IV) infusion
300 µg via intravenous (IV) infusion
1 mg via intravenous (IV) infusion
3 mg via intravenous (IV) infusion
10 mg via intravenous (IV) infusion
30 mg via intravenous (IV) infusion
70 mg via intravenous (IV) infusion
IV Infusion
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07030712