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MK-1484

Phase 1

Advanced or Metastatic Solid Tumors | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Nov 14, 2024

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 Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05382325A Study of MK-1484 as Monotherapy and in Combination With Pembrolizumab (MK-3475) In Advanced or Metastatic Solid Tumors (MK-1484-001)PHASE1 ACTIVE NOT_RECRUITING 70Jun 16, 2022Jul 31, 2026Nov 14, 20248 United States, Canada +2
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Study Endpoints
Primary Endpoints
Number of Participants with a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 5.0
Cycle 1 (Up to 21 days)

DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment: Grade (Gr) 4 nonhematologic toxicity (not laboratory); Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia: Gr 4 thrombocytopenia of any duration; Gr 3 thrombocytopenia associated with clinically significant bleeding; Gr 4 anemia regardless of duration; Nonhematologic AE Gr ≥3 in severity, with exceptions; Any Gr 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required, or if abnormality leads to hospitalization, persists for \>1 week or results in drug-induced liver injury with exceptions; Gr 3 or Gr 4 febrile neutropenia; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1; Missing \>25% of the MK-1484 dose during Cycle 1 resulting from treatment-related AE; Gr 5 toxicity.

Number of Participants Who Experience At Least One AE
Up to approximately 27 months

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. The number of participants who experienced an AE will be reported.

Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 24 months

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. The number of participants who discontinued study treatment due to an AE will be reported.

Secondary Endpoints
Area Under the Curve (AUC) of MK-1484
At designated time points (Up to approximately 24 months)
Minimum Serum Concentration (Cmin) of MK-1484
At designated time points (Up to approximately 24 months)
Maximum Serum Concentration (Cmax) of MK-1484
At designated time points (Up to approximately 24 months)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-1484EXPERIMENTALParticipants will receive MK-1484 every 3 weeks (Q3W) or 21-day cycle at escalating dose levels from 0.2-60 mg for up to a total of 35 cycles (up to approximately 24 months).
MK-1484 + PembrolizumabEXPERIMENTALParticipants will receive MK-1484 Q3W at escalating dose levels from 10-60 mg plus pembrolizumab 200 mg once every 21-day cycle for up to a total of 35 cycles (up to approximately 24 months).
Interventions
NameTypeDescription
MK-1484BIOLOGICALSubcutaneous (SC) injection
PembrolizumabBIOLOGICALIntravenous (IV) infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has a histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and has received, or been intolerant to, all treatment known to confer clinical benefit...

Countries:United StatesCanadaIsraelNetherlands
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05382325primaryCompletionDate: changed
LOWMay 24, 2026NCT05382325studyFirstPostDate: changed