NCT07030712PHASE1Recruiting
A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)
Merck Sharp & Dohme LLC
Start Date
7/23/2025
Completion Date
7/1/2029
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 Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
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
Exclusion Criteria:
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
Interventions
DRUG
MK-8294
DRUG
MK-8294
DRUG
MK-8294
DRUG
MK-8294
DRUG
MK-8294
DRUG
MK-8294
DRUG
MK-8294
DRUG
MK-8294
OTHER
CD8 PET Tracer
Conditions
Metastatic Neoplasm
Locations
Northwestern University ( Site 0101)
Chicago, Illinois 60611
United States
Houston Methodist Hospital ( Site 0103)
Houston, Texas 77030
United States
Rambam Health Care Campus ( Site 0201)
Haifa, 3109601
Israel
Sheba Medical Center ( Site 0200)
Ramat Gan, 5265601
Israel
Radboudumc ( Site 0301)
Nijmegen, Gelderland 6525 GA
Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0300)
Amsterdam, North Holland 1066 CX
Netherlands