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Navlimetostat

Phase 2

Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Sep 2, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment470

FDA Designations

No designations recorded

Clinical trial landscape

Navlimetostat · 4 trials · 4 indications

Phase 2 1Phase 1 3
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
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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

Maximum observed plasma concentration (Cmax)
Up to 14 days
Time of maximum observed plasma concentration (Tmax)
Up to 14 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Up to 14 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to 14 days
Terminal elimination half-life (T-HALF)
Up to 14 days
Apparent total body clearance (CLT/F)
Up to 14 days
Apparent volume of distribution during the terminal phase (VZ/F)
Up to 14 days
Percent of plasma navlimetostat AUC(INF) to plasma radioactivity AUC(INF) (%AUC(INF))
Up to 14 days
Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF)
Up to 14 days
Total amount of dose recovered in urine (UR)
Up to 14 days
Percent of administered dose recovered in urine (%UR)
Up to 14 days
Renal clearance (CLR)
Up to 14 days
TRA from UR
Up to 14 days
TRA from %UR
Up to 14 days
TRA from total amount of dose recovered in feces (FR)
Up to 14 days
TRA from percent of administered dose recovered in feces (%FR)
Up to 14 days
TRA from total amount of radioactivity recovered (Rtotal)
Up to 14 days
TRA from total percent of radioactivity recovered (%TOTAL)
Up to 14 days
TRA amount recovered of the radioactive dose in vomit, if applicable
Up to 14 days
TRA fraction of the radioactive dose in vomit, if applicable
Up to 14 days
Maximum observed concentration (Cmax) of Navlimetostat
Up to approximately 3 weeks

Part 1A, Part 1B, Part 3, Part 4

Area under the concentration-time curve from time zero to 192 hours (AUC(0-192)) of Navlimetostat
Up to approximately 3 weeks

Part 1A

(AUC(INF)) of Navlimetostat with the coadministration of itraconazole
Up to approximately 3 weeks

Part 1A

AUC(INF) of Navlimetostat without the coadministration of itraconazole
Up to approximately 3 weeks

Part 1A

Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Navlimetostat
Up to approximately 3 weeks

Part 1B, Part 3, Part 4

AUC(INF) of Navlimetostat with the coadministration of Rifampin
Up to approximately 3 weeks

Part 1B

AUC(INF) of Navlimetostat without the coadministration of Rifampin
Up to approximately 3 weeks

Part 1B

Cmax of Midazolam
Up to approximately 3 weeks

Part 2

AUC(0-T) of Midazolam
Up to approximately 3 weeks

Part 2

AUC(INF) of Midazolam with the coadministration of Navlimetostat
Up to approximately 3 weeks

Part 2

AUC(INF) of Midazolam without the coadministration of Navlimetostat
Up to approximately 3 weeks

Part 2

AUC(INF) of Navlimetostat with a high fat meal
Up to approximately 3 weeks

Part 3

AUC(INF) of Navlimetostat without a high fat meal
Up to approximately 3 weeks

Part 3

AUC(INF) of Navlimetostat with the coadministration of Pantoprazole
Up to approximately 3 weeks

Part 4

AUC(INF) of Navlimetostat without the coadministration of Pantoprazole
Up to approximately 3 weeks

Part 4

Drug-related AEs
Up to approximately 6 weeks
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
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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 -
Part AEXPERIMENTAL -
Part BEXPERIMENTAL -
Part 1AEXPERIMENTAL -
Part 1BEXPERIMENTAL -
Part 2EXPERIMENTAL -
Part 3EXPERIMENTAL -
Part 4EXPERIMENTAL -
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
[14C]NavlimetostatDRUGSpecified dose on specified days
ItraconazoleDRUGSpecified dose on specified days
RifampinDRUGSpecified dose on specified days
MidazolamDRUGSpecified dose on specified days
PantoprazoleDRUGSpecified dose on specified days
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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
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Recent Changes (Last 90 Days)

LOWSep 2, 2026NCT07800897NEW_TRIAL: changed
LOWSep 2, 2026NCT07800897NEW_TRIAL: changed
LOWSep 2, 2026NCT07800897NEW_TRIAL: changed
LOWAug 20, 2026NCT07777133NEW_TRIAL: changed
LOWAug 20, 2026NCT07777133NEW_TRIAL: changed
LOWJun 24, 2026NCT07544628lastUpdatePostDate: changed
LOWJun 24, 2026NCT07544628lastUpdatePostDate: changed

Frequently asked questions about Navlimetostat

What is Navlimetostat used for?

Navlimetostat is an investigational small molecule being studied for pancreatic ductal adenocarcinoma and in healthy participant trials. The main efficacy study evaluates Navlimetostat combined with nab-paclitaxel and gemcitabine versus placebo with those drugs in untreated metastatic pancreatic ductal adenocarcinoma with homozygous MTAP deletion.

What does Navlimetostat target?

Navlimetostat is a -stat class enzyme inhibitor, meaning it targets an enzyme. The specific molecular target is not disclosed in the available information. It is being studied in tumors with homozygous MTAP deletion, which may relate to its mechanism of action.

Who makes Navlimetostat?

Navlimetostat is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials of the drug across multiple countries.

What phase is Navlimetostat in?

Navlimetostat is in Phase 1 and Phase 2 clinical development. The Phase 2 study is active but not recruiting, while two Phase 1 studies are recruiting or not yet recruiting. It is investigational and not approved by the FDA.

What clinical trials is Navlimetostat in?

Navlimetostat has three registered trials. NCT07076121 is a Phase 2 study in metastatic pancreatic ductal adenocarcinoma. NCT07544628 is a Phase 1 study of tablet formulations in healthy participants. NCT07777133 is a Phase 1 metabolism study in healthy female participants.

Is Navlimetostat the same as BMS-986504?

Yes, Navlimetostat is also known as BMS-986504. Clinical trial titles refer to the drug as Navlimetostat (BMS-986504), confirming these names refer to the same investigational compound.