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

NCT ID: NCT07030712

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-23

Study Completion Date

2027-08-23

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MK-8294

Intervention Type DRUG

30 µg via intravenous (IV) infusion

MK-8294

Intervention Type DRUG

100 µg via intravenous (IV) infusion

MK-8294

Intervention Type DRUG

300 µg via intravenous (IV) infusion

MK-8294

Intervention Type DRUG

1 mg via intravenous (IV) infusion

MK-8294

Intervention Type DRUG

3 mg via intravenous (IV) infusion

MK-8294

Intervention Type DRUG

10 mg via intravenous (IV) infusion

MK-8294

Intervention Type DRUG

30 mg via intravenous (IV) infusion

MK-8294

Intervention Type DRUG

70 mg via intravenous (IV) infusion

Interventions

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MK-8294

30 µg via intravenous (IV) infusion

Intervention Type DRUG

MK-8294

100 µg via intravenous (IV) infusion

Intervention Type DRUG

MK-8294

300 µg via intravenous (IV) infusion

Intervention Type DRUG

MK-8294

1 mg via intravenous (IV) infusion

Intervention Type DRUG

MK-8294

3 mg via intravenous (IV) infusion

Intervention Type DRUG

MK-8294

10 mg via intravenous (IV) infusion

Intervention Type DRUG

MK-8294

30 mg via intravenous (IV) infusion

Intervention Type DRUG

MK-8294

70 mg via intravenous (IV) infusion

Intervention Type DRUG

Other Intervention Names

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DAB014236 DAB014236 DAB014236 DAB014236 DAB014236 DAB014236 DAB014236 DAB014236

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Northwestern University ( Site 0101)

Chicago, Illinois, United States

Site Status RECRUITING

Rambam Health Care Campus ( Site 0201)

Haifa, , Israel

Site Status RECRUITING

Sheba Medical Center ( Site 0200)

Ramat Gan, , Israel

Site Status RECRUITING

Radboudumc ( Site 0301)

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

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

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Countries

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United States Israel Netherlands

Central Contacts

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Toll Free Number

Role: CONTACT

1-888-577-8839

Facility Contacts

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Study Coordinator

Role: primary

312-926-8105

Study Coordinator

Role: primary

972(47776234)

Study Coordinator

Role: primary

972(35307039)

Study Coordinator

Role: primary

0243611111

Study Coordinator

Role: primary

+31205129111

Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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2024-516870-31-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1311-2807

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-8294-001

Identifier Type: OTHER

Identifier Source: secondary_id

8294-001

Identifier Type: -

Identifier Source: org_study_id

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