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MK-0472

Phase 1

Metastatic Solid Tumors | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Mar 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment178
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05853367Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)PHASE1 RECRUITING 178Jul 6, 2023Feb 12, 2028Mar 13, 202625 United States, Canada +5
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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 56 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 56 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.

Secondary Endpoints
Area Under the Concentration Time-curve From Time 0 to the End of the Dosing Period (AUCtau) of MK-0472
At predetermined timepoints predose and postdose up to Cycle 6 (Each cycle length = 21 Days)
Lowest Plasma Concentration (Ctrough) of MK-0472
At predetermined timepoints Predose up to Cycle 6 (Each cycle length = 21 Days)
Maximum Plasma Concentration (Cmax) of MK-0472
At predetermined timepoints postdose up to Cycle 6 (Each cycle length = 21 Days)
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05853367primaryCompletionDate: changed
LOWMay 24, 2026NCT05853367studyFirstPostDate: changed