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MK-4716

Phase 1

Malignant Neoplasm | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Jun 3, 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 Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07247110A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)PHASE1 RECRUITING 250Dec 16, 2025Dec 1, 2030Jun 3, 202619 United States, Australia +5
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Study Endpoints
Primary Endpoints
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT)
Up to approximately 28 days

A DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.

Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 4 years

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Number of Participants Who Discontinue Study Intervention Due to an AE
Up to approximately 4 years

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Secondary Endpoints
Area Under the Concentration-Time Curve (AUC) of MK-4716
At designated timepoints (up to approximately 58 days)
Maximum Plasma Concentration (Cmax) of MK-4716
At designated timepoints (up to approximately 58 days)
Trough Plasma Concentration (Ctrough) of MK-4716
At designated timepoints (up to approximately 19 months)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-4716 Dose EscalationEXPERIMENTALParticipants receive MK-4716 at varying dose levels and schedules.
MK-4716 + PembrolizumabEXPERIMENTALParticipants will receive MK-4716 + Pembrolizumab
MK-4716 + CetuximabEXPERIMENTALParticipants will receive MK-4716 + Cetuximab
Interventions
NameTypeDescription
MK-4716DRUGOral administration
PembrolizumabBIOLOGICALIntravenous administration
CetuximabBIOLOGICALIntravenous administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumor * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Must demonstrate presence of Kirsten...

Countries:United StatesAustraliaCanadaChileIsraelSouth KoreaSpain
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07247110lastUpdatePostDate: changed
LOWJun 4, 2026NCT07247110lastUpdatePostDate: changed
LOWJun 4, 2026NCT07247110lastUpdatePostDate: changed
LOWJun 4, 2026NCT07247110lastUpdatePostDate: changed
LOWJun 4, 2026NCT07247110lastUpdatePostDate: changed
LOWMay 26, 2026NCT07247110primaryCompletionDate: changed
LOWMay 24, 2026NCT07247110studyFirstPostDate: changed