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NCT Number: NCT07030712

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

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.

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Key information

Conditions

Metastatic Neoplasm Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rambam Health Care Campus ( Site 0201), Haifa, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-8294

Drug

30 µg via intravenous (IV) infusion

Other names: DAB014236

CD8 PET Tracer

Other

IV Infusion

Other names: GEH200520 + GEH200521 (18F)

Primary outcomes

  1. Number of participants who experience one or more dose-limiting toxicities (DLTs)

    Time frame: Up to approximately 35 days

    DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period (up to 35 days) that results in a change to a given dose or a delay in initiating the next treatment and reported as the number of participants experiencing a DLT.

  2. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 2 years

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

  3. Number of Participants Who Discontinue Study Intervention Due to an AE

    Time frame: Up to approximately 2 years

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study/study treatment due to an AE will be reported.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.

  2. Area Under the Plasma Concentration-Time Curve (AUC) of MK-8294

    Time frame: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)

    Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Area Under the Concentration-Time Curve of MK-8294.

  3. Minimum Concentration (Cmin) of MK-8294

    Time frame: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)

    Cmin is defined as the lowest concentration of MK-8294 after administration of MK-8294. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Cmin of MK-8294.

  4. Maximum Plasma Concentration (Cmax) of MK-8294

    Time frame: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)

    Cmax is defined as the peak concentration of MK-8294 after administration of MK-8294. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Cmax of MK-8294.

  5. Time to Maximum Plasma Concentration (Tmax) of MK-8294

    Time frame: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)

    Tmax is defined as the time to reach Cmax. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Tmax of MK-8294.

  6. Incidence of Antidrug Antibodies (ADA) to MK-8294

    Time frame: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)

    Blood samples will be collected pre-dose and at designated time points to determine the ADA response to MK-8294. The incidence of ADAs over time will be presented.

  7. Titer of ADA to MK-8294

    Time frame: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)

    Blood samples will be collected pre-dose and at designated time points to determine the ADA titers to MK-8294.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 1 Open-label Study to Evaluate the Safety and Efficacy of MK-8294 Monotherapy in Advanced Solid Tumors

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 22, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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