Recruiting

Phase 1

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07030712

Conditions

Metastatic Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MK-8294

Study Details

Brief 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.

Conditions

Metastatic Neoplasm

Study ID

NCT07030712

Start date

Jul 23, 2025

Status verified date

Oct, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

67 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

MK-8294

30 µg via intravenous (IV) infusion

MK-8294

100 µg via intravenous (IV) infusion

MK-8294

300 µg via intravenous (IV) infusion

MK-8294

1 mg via intravenous (IV) infusion

MK-8294

3 mg via intravenous (IV) infusion

MK-8294

10 mg via intravenous (IV) infusion

MK-8294

30 mg via intravenous (IV) infusion

MK-8294

70 mg via intravenous (IV) infusion

CD8 PET Tracer

IV Infusion

Primary outcome measure

Number of participants who experience one or more dose-limiting toxicities (DLTs) [ Time Frame: Up to approximately 35 days ]
Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 2 years ]
Number of Participants Who Discontinue Study Intervention Due to an AE [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Northwestern University ( Site 0101)

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Study Coordinator

312-926-8105

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0105)

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-5900

Houston Methodist Hospital ( Site 0103)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

346-238-4516

MD Anderson Cancer Center ( Site 0104)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-563-1930

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

Metastases
Neoplasm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.