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A Study of MK-8294 for Advanced Solid Tumors

This study is testing a new medicine called MK-8294 for people with advanced solid tumors (cancers that have spread). MK-8294 is a type of targeted therapy, meaning it's designed to attack specific cancer cells. The main goals are to understand how safe MK-8294 is, how well people can tolerate it, and to find the highest dose that can be given safely. Researchers will be looking for side effects and how many people need to stop the treatment because of them. The study is open to adults aged 18 and older with various types of advanced solid tumors, including breast cancer and head and neck cancer. This study is currently recruiting about 67 participants.

Study design
This is an interventional study, meaning participants will receive MK-8294 at different doses (30 µg, 100 µg, 300 µg, 1 mg, or 3 mg) given intravenously (into a vein).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events (side effects) for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07030712

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~67 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:MK-8294CD8 PET Tracer

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who experience one or more dose-limiting toxicities (DLTs)
Measured over Up to approximately 35 days
+2 more outcomes measured

Conditions

Metastatic Neoplasm

Explore related trials

Bladder CarcinomaBreast CarcinomaCervical Squamous Cell CarcinomaEndometrial CarcinomaEsophageal Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaSolid Neoplasm

Where it's being run

5 sites across 4 states
Israel2
Illinois1
Gelderland1
North Holland1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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

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

  • Number of Participants Who Discontinue Study Intervention Due to an AEUp 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.