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

NCT07030712 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: 8294-0012024-516870-31-00U1111-1311-2807MK-8294-001
• Study Type: interventional
• Target: 67
• Locations: 3 countries
• Sites: 5

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

Keywords

Metastases; Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to approximately 2 years

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  Up to approximately 2 years

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

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

• Minimum Concentration (Cmin) of MK-8294

  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

  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

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

Study Arms (1)

MK-8294

EXPERIMENTAL

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; Other: CD8 PET Tracer

Interventions

CD8 PET Tracer OTHER

IV Infusion

Also known as: GEH200520 + GEH200521 (18F)

MK-8294

MK-8294 DRUG

30 µg via intravenous (IV) infusion

Also known as: DAB014236

MK-8294

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (5)

Northwestern University ( Site 0101)

Chicago, Illinois, 60611, United States

RECRUITING

Rambam Health Care Campus ( Site 0201)

Haifa, 3109601, Israel

RECRUITING

Sheba Medical Center ( Site 0200)

Ramat Gan, 5265601, Israel

RECRUITING

Radboudumc ( Site 0301)

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0300)

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): August 23, 2027
• Study Completion (Estimated): August 23, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

NL (2); IL (2); US (1)