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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Metastatic Neoplasm

Treatments: Drug: MK-8294

Study type: Interventional

Funder types: Industry

Identifiers

NCT07030712

2024-516870-31-00 (Registry Identifier)

MK-8294-001 (Other Identifier)

U1111-1311-2807 (Registry Identifier)

8294-001

Details and patient eligibility

About

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.

Enrollment: 47 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 received, or been intolerant to/failed, all treatment known to confer clinical benefit
• 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 Yok 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 history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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47 participants in 1 patient group

MK-8294

Experimental group

Description:

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.

Treatment:

Drug: MK-8294

Drug: MK-8294

Drug: MK-8294

Drug: MK-8294

Drug: MK-8294

Drug: MK-8294

Drug: MK-8294

Drug: MK-8294