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MK-8294

Phase 1

Metastatic Neoplasm | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Aug 28, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment67

FDA Designations

No designations recorded

Clinical trial landscape

MK-8294 · 1 trial · 1 indication

Phase 1 1
NCT07030712A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)Metastatic Neoplasm
RECRUITING67 Analytics
PHASE1RECRUITING
A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)
Metastatic NeoplasmUnlock trial analytics

Study Endpoints

Primary Endpoints

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 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 discontinue study/study treatment due to an AE will be reported.

Secondary Endpoints

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)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-8294EXPERIMENTALParticipants 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

NameTypeDescription
MK-8294DRUG30 µg via intravenous (IV) infusion
CD8 PET TracerOTHERIV Infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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, brea...

Countries:United StatesIsraelNetherlands
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Recent Changes (Last 90 Days)

LOWAug 28, 2026NCT07030712lastUpdatePostDate: changed
LOWAug 28, 2026NCT07030712lastUpdatePostDate: changed
MEDIUMJul 17, 2026NCT07030712primaryCompletionDate: changed
MEDIUMJul 17, 2026NCT07030712primaryCompletionDate: changed
LOWJul 13, 2026NCT07030712lastUpdatePostDate: changed
LOWJul 13, 2026NCT07030712lastUpdatePostDate: changed

Frequently asked questions about MK-8294

What is MK-8294 used for?

MK-8294 is an investigational small molecule being developed for the treatment of metastatic neoplasms, which are advanced solid tumors that have spread from their original site. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes MK-8294?

MK-8294 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is MK-8294 in?

MK-8294 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing clinical trials to assess its safety, tolerability, and potential efficacy in patients with advanced solid tumors.

What clinical trials is MK-8294 in?

MK-8294 is being studied in a Phase 1 clinical trial with the identifier NCT07030712, titled "A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)." This trial is currently recruiting participants and aims to enroll 67 patients with metastatic neoplasms.

Is MK-8294 the same as any other drug?

No alternative names for MK-8294 have been identified. It is a unique investigational compound developed by Merck & Company, Inc., and is being studied under its current designation in clinical trials.