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RecruitingInterventionalPhase 1

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

NCT ID: NCT07030712Sponsor: Merck Sharp & Dohme LLCLast updated: 2026-03-16

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.

Arms & interventions

  • DrugMK-8294

    30 µg via intravenous (IV) infusion

  • DrugMK-8294

    100 µg via intravenous (IV) infusion

  • DrugMK-8294

    300 µg via intravenous (IV) infusion

  • DrugMK-8294

    1 mg via intravenous (IV) infusion

  • DrugMK-8294

    3 mg via intravenous (IV) infusion

  • DrugMK-8294

    10 mg via intravenous (IV) infusion

  • DrugMK-8294

    30 mg via intravenous (IV) infusion

  • DrugMK-8294

    70 mg via intravenous (IV) infusion

  • OtherCD8 PET Tracer

    IV Infusion

Outcome measures

Primary

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

    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.

    Time frame: Up to approximately 35 days

  • Number of Participants Who Experience an Adverse Event (AE)

    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.

    Time frame: Up to approximately 2 years

  • Number of Participants Who Discontinue Study Intervention Due to an AE

    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.

    Time frame: Up to approximately 2 years

Secondary

  • Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (1)

Northwestern University ( Site 0101)

Chicago, Illinois, 60611

Recruiting
Study Coordinator · Contact
A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001) | Cancerify