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Navlimetostat

Phase 2

Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |Bristol-Myers Squibb Company|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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment470
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07076121A Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30)PHASE2 ACTIVE NOT_RECRUITING 470Oct 23, 2025May 3, 2029Jun 3, 2026269 United States, Argentina +34
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Study Endpoints
Primary Endpoints
Progression-Free Survival as assessed by Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1)
Up to 3 years after last participant is randomized

Defined as the time between the randomization date and the date of progressive disease (PD) or death from any cause (whichever occurs first)

Overall Survival (OS)
Up to 3 years after last participant is randomized

Defined as the time from the randomization date to the date of death from any cause

Secondary Endpoints
Objective Response (OR) as assessed by RECIST v1.1
Up to 3 years after last participant is randomized
Duration of Response (DOR) as assessed by RECIST v1.1
Up to 3 years after last participant is randomized
Time to Objective Response (TTOR) as assessed by RECIST v1.1
Up to 3 years after last participant is randomized
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BEXPERIMENTAL -
Arm CPLACEBO_COMPARATOR -
Arm DPLACEBO_COMPARATOR -
Arm EEXPERIMENTAL -
Arm FPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
NavlimetostatDRUGSpecified dose on specified days
GemcitabineDRUGSpecified dose on specified days
Nab-paclitaxelDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites269

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC). * Evidence of homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss detected in tumor tissue. * Metastatic disease with at least 1 measurable lesion a...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChileChinaColombiaCzechiaDenmarkFranceGermanyGreeceHong KongIndiaIrelandIsraelItalyJapanMalaysiaMexicoNetherlandsPolandRomaniaSingaporeSlovakiaSouth AfricaSouth KoreaSpainSwedenSwitzerlandTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
MEDIUMJun 4, 2026NCT07076121Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 4, 2026NCT07076121Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 4, 2026NCT07076121Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 4, 2026NCT07076121Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 4, 2026NCT07076121Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT07076121primaryCompletionDate: changed
LOWMay 24, 2026NCT07076121studyFirstPostDate: changed