Recent Updates
Recently added Catalysts

Navlimetostat

Phase 2

Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 24, 2026

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment470
FDA Designations
No designations recorded
Clinical trial landscape

Navlimetostat · 2 trials · 2 indications

Phase 2 1Phase 1 1
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)Pancreatic Ductal Adenocarcinoma
ACTIVE NOT_RECRUITING470 Analytics
PHASE2ACTIVE NOT_RECRUITING
A 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)
Pancreatic Ductal Adenocarcinoma
NCT07076121470
Unlock trial analytics
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

Maximum Plasma Concentration (Cmax)
Up to Day 17
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Up to Day 17
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Up to Day 17
Number of participants with Adverse Events (AE)
Up to approximately day 37
Number of participants with Serious Adverse Events (AE)
Up to approximately day 37
Number of participants with clinically significant changes in Physical Examinations (PE)
Up to Day 17
Number of participants with clinically significant changes in vital signs (VS)
Up to Day 17
Number of participants with clinically significant changes in 12-lead ECGs
Up to Day 17
Number of participants with clinically significant changes in laboratory tests results
Up to Day 17
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
Unlock Study Endpoints
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 -
Treatment AEXPERIMENTAL -
Treatment BEXPERIMENTAL -
Interventions
NameTypeDescription
NavlimetostatDRUGSpecified dose on specified days
GemcitabineDRUGSpecified dose on specified days
Nab-paclitaxelDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to 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
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWJun 24, 2026NCT07544628lastUpdatePostDate: changed
LOWJun 24, 2026NCT07544628lastUpdatePostDate: changed
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, 2026NCT07544628studyFirstPostDate: changed
LOWMay 24, 2026NCT07076121studyFirstPostDate: changed
LOWMay 21, 2026NCT07544628NEW_TRIAL: changed
LOWMay 21, 2026NCT07544628NEW_TRIAL: changed