Health Trials

A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)

ConditionMetastatic Neoplasm
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MK-8294
  • MK-8294
  • MK-8294
  • MK-8294
  • MK-8294
  • MK-8294
  • MK-8294
  • MK-8294
  • CD8 PET Tracer

Treatment groups

67 Participants
are divided into 1 treatment group

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

Source ClinicalTrials.gov