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MK-0472

Phase 1

Metastatic Solid Tumors | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Aug 7, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment95

FDA Designations

No designations recorded

Clinical trial landscape

MK-0472 · 1 trial · 2 indications

Phase 1 1
NCT05853367Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)Metastatic Solid Tumors
ACTIVE NOT_RECRUITING95 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)
Metastatic Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Who Experience a Dose Limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
At the end of Cycle 1 (each cycle is 21 days)

DLT will be defined as any drug-related AE observed during the DLT evaluation period (e.g. Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle.

Number of Participants Who Experience One or More Adverse Events (AEs)
Up to approximately 60 months

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE's will be reported.

Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Up to approximately 60 months

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-0472EXPERIMENTALParticipants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation.
MK-0472 + PembrolizumabEXPERIMENTALParticipants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation, plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
MK-0472 + MK-1084EXPERIMENTALParticipants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens, plus MK-1084 via oral capsule until disease progression or withdrawal/discontinuation.

Interventions

NameTypeDescription
MK-0472DRUGOral Administration
PembrolizumabBIOLOGICALIV infusion
MK-1084DRUGOral Administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed solid tumor by pathology report that is advanced/metastatic * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have re...

Countries:United StatesCanadaChileIsraelPolandSpainSwitzerland
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Metastatic Solid Tumors")

Recent Changes (Last 90 Days)

LOWAug 8, 2026NCT05853367lastUpdatePostDate: changed
LOWAug 8, 2026NCT05853367lastUpdatePostDate: changed
LOWAug 8, 2026NCT05853367lastUpdatePostDate: changed
LOWAug 8, 2026NCT05853367lastUpdatePostDate: changed
LOWJul 17, 2026NCT05853367primaryCompletionDate: changed
LOWJul 17, 2026NCT05853367primaryCompletionDate: changed
HIGHJul 15, 2026NCT05853367Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJul 15, 2026NCT05853367Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 16, 2026NCT05853367lastUpdatePostDate: changed
LOWJun 16, 2026NCT05853367lastUpdatePostDate: changed
LOWJun 16, 2026NCT05853367lastUpdatePostDate: changed
LOWJun 16, 2026NCT05853367lastUpdatePostDate: changed

Frequently asked questions about MK-0472

What is MK-0472 used for?

MK-0472 is an investigational small molecule being developed for the treatment of metastatic solid tumors and advanced solid tumors. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.

Who makes MK-0472?

MK-0472 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 drug's potential in treating patients with advanced or metastatic solid tumors.

What phase is MK-0472 in?

MK-0472 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is active but not recruiting participants, and the drug is being studied for safety and dosing in patients with advanced or metastatic solid tumors.

What clinical trials is MK-0472 in?

MK-0472 is being studied in a Phase 1 clinical trial with the identifier NCT05853367, titled "Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)." This trial is active but not recruiting, with an estimated enrollment of 95 participants across multiple countries including the United States, Canada, Chile, Israel, Poland, Spain, and Switzerland.

Is MK-0472 FDA approved?

MK-0472 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials for the treatment of advanced or metastatic solid tumors. The drug is still in early-stage clinical development, and its safety and effectiveness have not yet been established for regulatory approval.