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MRTX1719

Phase 1

Mesothelioma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Dec 5, 2025

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 Enrollment336
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05245500Phase 1 Study of MRTX1719 in Solid Tumors With MTAP DeletionPHASE1 RECRUITING 336Jun 9, 2022Dec 10, 2027Dec 5, 202525 United States
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Study Endpoints
Primary Endpoints
Number of Patients who Experience Dose-Limiting Toxicity
21 days
Number of patients who experience a treatment-related adverse event
Up to 2 years
Objective response rate (ORR)
2 years
Duration of response (DOR)
2 years
Progression free survival (PFS)
2 years
Overall survival (OS)
2 years
Number of Patients With Clinically Significant Laboratory Assessments
Up to 4 years
Secondary Endpoints
Area under the plasma concentration versus time curve (AUC)
Up to 4 days
Time to achieve maximal plasma concentration (Tmax)
Up to 4 days
Maximum observed plasma concentration (Cmax)
Up to 4 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1/1BEXPERIMENTALDose Escalation/Evaluation
Phase 1b Sub-studies 1-4EXPERIMENTAL -
Phase 1b Sub-study 5EXPERIMENTAL -
Interventions
NameTypeDescription
MRTX1719DRUGMRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria * Histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue. * Unresectable or metastatic disease. * Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-s...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05245500primaryCompletionDate: changed
LOWMay 24, 2026NCT05245500studyFirstPostDate: changed