Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MK-8294
Participants will receive MK-8294 monotherapy in escalating doses starting from 30 µg up to a planned 70 mg via intravenous (IV) infusion. In addition, intermediate doses may also be assessed. MK-8294 will be administered on Day 1, Day 8, and Day 15 of each cycle (each cycle = 21 days). Per protocol treatment of MK-8294 has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met. Participants may also receive a cluster of differentiation 8 (CD8) positron emission tomography (PET) tracer as a part of optional PET imaging.
  • Drug: MK-8294
    30 µg via intravenous (IV) infusion
    Other names:
    • DAB014236
  • Drug: MK-8294
    100 µg via intravenous (IV) infusion
    Other names:
    • DAB014236
  • Drug: MK-8294
    300 µg via intravenous (IV) infusion
    Other names:
    • DAB014236
  • Drug: MK-8294
    1 mg via intravenous (IV) infusion
    Other names:
    • DAB014236
  • Drug: MK-8294
    3 mg via intravenous (IV) infusion
    Other names:
    • DAB014236
  • Drug: MK-8294
    10 mg via intravenous (IV) infusion
    Other names:
    • DAB014236
  • Drug: MK-8294
    30 mg via intravenous (IV) infusion
    Other names:
    • DAB014236
  • Drug: MK-8294
    70 mg via intravenous (IV) infusion
    Other names:
    • DAB014236
  • Other: CD8 PET Tracer
    IV Infusion
    Other names:
    • GEH200520 + GEH200521 (18F)

Recruiting Locations

Northwestern University ( Site 0101)
Chicago, Illinois 60611
Contact:
Study Coordinator
312-926-8105

Houston Methodist Hospital ( Site 0103)
Houston, Texas 77030
Contact:
Study Coordinator
346-238-4516

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.