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Navlimetostat

Phase 2

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Oct 6, 2026

Navlimetostat development status

Highest phase Phase 2
Registered trials 13 across 4 sponsors since Feb 2022

Navlimetostat target and mechanism

Target class-Stat (Enzyme)
ModalitySmall molecule

Also known as BMS-986504, MRTX1719

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials8
Total Enrollment1,908

FDA Designations

No designations recorded

Navlimetostat clinical trials

Navlimetostat · 8 trials · 12 indications

Phase 2 5Phase 1 3
NCT07492680A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)Solid Tumors
RECRUITING260 Analytics
NCT07602946SELECTmeso A Trial for Patients With Relapsed Malignant Mesothelioma SELECTmeso1 A Trial of BMS-986504 in Patients With MTAP-deficient Relapsed MesotheliomaMesothelioma
NOT YET_RECRUITING30 Analytics
NCT07063745A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP DeletionMetastatic Non-small Cell Lung Cancer With MTAP Deletion
RECRUITING590 Analytics
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
NCT06855771A Study of Navlimetostat (BMS-986504) Alone or in Combination With Izalontamab Brengitecan in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion or MTAP Loss (MountainTAP-9)Carcinoma, Non-Small-Cell Lung
RECRUITING182 Analytics
PHASE2RECRUITING
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
NCT07492680260
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PHASE2NOT YET_RECRUITING
SELECTmeso A Trial for Patients With Relapsed Malignant Mesothelioma SELECTmeso1 A Trial of BMS-986504 in Patients With MTAP-deficient Relapsed Mesothelioma
Mesothelioma
NCT0760294630
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PHASE2RECRUITING
A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
Metastatic Non-small Cell Lung Cancer With MTAP Deletion
NCT07063745590
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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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PHASE2RECRUITING
A Study of Navlimetostat (BMS-986504) Alone or in Combination With Izalontamab Brengitecan in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion or MTAP Loss (MountainTAP-9)
Carcinoma, Non-Small-Cell Lung
NCT06855771182
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Study Endpoints

Primary Endpoints

Part 1: Number of participants who achieve Objective Response (OR)
Up to approximately 2 years

OR is defined as confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Response Assessment in Neuro-Oncology (RANO) v2 or Modified RECIST v1.1

Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria
Up to approximately 2 years
Part 2: Number of participants with adverse events (AE)
Up to approximately 2 years
Part 2: Number of participants with Serious AEs (SAEs)
Up to approximately 2 years
Part 2: Number of participants with treatment related AEs
Up to approximately 2 years
Part 2: Number of participants with treatment related SAEs
Up to approximately 2 years
Part 2: Number of participants with AEs leading to study treatment discontinuation
Up to approximately 2 years
Part 2: Number of participants with AEs leading to death
Up to approximately 2 years
Part 2: Number of participants with laboratory abnormalities
Up to approximately 2 years
SELECTmeso Platform : Molecular profiling of participant's tumour block SELECTmeso1: Disease Control Rate (DCR) using RECIST 1.1 at 12 weeks.
SELECTmeso Platform: Baseline SELECTmeso1: at 12 weeks of treatment
Progression-free survival (PFS) by RECIST v1.1
Up to 2 years

Phase 2

PFS by RECIST v1.1 per BICR
Up to 5 years

Phase 3

Overall Survival (OS)
Up to 5 years

Phase 3

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)

Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Up to 3 years after the last participant's last dose of study treatment

OR is defined as confirmed complete response (CR) or partial response (PR)

Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria
Up to 28 days after the last dose of study treatment

Arm C and Arm D

Number of participants with adverse events (AE)
Up to 28 days after the last dose of study treatment

Arm C and Arm D

Number of participants with Serious AEs (SAEs)
Up to 28 days after the last dose of study treatment

Arm C and Arm D

Number of participants with treatment related AEs
Up to 28 days after the last dose of study treatment

Arm C and Arm D

Number of participants with treatment related SAEs
Up to 28 days after the last dose of study treatment

Arm C and Arm D

Number of participants with AEs leading to study treatment discontinuation
Up to 28 days after the last dose of study treatment

Arm C and Arm D

Number of participants with AEs leading to death
Up to 28 days after the last dose of study treatment

Arm C and Arm D

Number of participants with laboratory abnormalities
Up to 28 days after the last dose of study treatment

Arm C and Arm D

Maximum Plasma Concentration (Cmax) of BMS-986504
Up to approximately Day 64
Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504
Up to approximately Day 64
Area Under Curve (AUC) of BMS-986504
Up to approximately Day 64
Mean Elimination Half-life (T-HALF) of BMS-986504
Up to approximately Day 64
Apparent Total Body Clearance (CLT/F) of BMS-986504
Up to approximately Day 64
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BMS-986504
Up to approximately Day 64
Maximum observed concentration (Cmax)
Up to 2 weeks
Time of maximum observed drug concentration (Tmax)
Up to 2 weeks
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Up to 2 weeks
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to 2 weeks
Terminal elimination half-life (T-HALF)
Up to 2 weeks
Apparent total body clearance (CLT/F)
Up to 2 weeks
Apparent volume of distribution during the terminal phase (Vz/F)
Up to 2 weeks
Percentage of estimated part for the calculation of AUC(INF) (%AUC(INF))
Up to 2 weeks
Blood-to-plasma total radioactivity (TRA) ratio
Up to 2 weeks
Total amount of administered dose recovered in urine (UR)
Up to 2 weeks
Percent of administered dose recovered in urine (%UR)
Up to 2 weeks
Renal clearance (CLR) in urine
Up to 2 weeks
Total radioactivity in UR
Up to 2 weeks
Total radioactivity in %UR
Up to 2 weeks
Total radioactivity in total amount of administered dose recovered in feces (FR)
Up to 2 weeks
Total radioactivity in percent of administered dose recovered in feces (%FR)
Up to 2 weeks
Total amount of radioactivity recovered (Rtotal)
Up to 2 weeks
Total percent of radioactivity recovered (%TOTAL)
Up to 2 weeks
TRA amount recovered and fraction of the radioactive dose in vomit if applicable
Up to 2 weeks
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
Number of Patients With Clinically Significant Laboratory Assessments
Up to 4 years

Secondary Endpoints

Part 1 and 2: Time to objective response (TTOR)
Up to approximately 2 years
Part 1 and 2: Duration of response (DOR)
Up to approximately 2 years
Part 1 and 2: Number of participants who achieve disease control (DC)
Up to approximately 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1aEXPERIMENTALBMS-986504
Part 1bEXPERIMENTALBMS-986504
Part 2: Cohort 1EXPERIMENTALBMS-986504 + Pumitamig + Chemotherapy
Part 2: Cohort 2aEXPERIMENTALBMS-986504 + Daraxonrasib
Part 2: Cohort 2bEXPERIMENTALBMS-986504 + Daraxonrasib
Part 2: Cohort 2cEXPERIMENTALBMS-986504 + Daraxonrasib + Chemotherapy
Part 2: Cohort 3EXPERIMENTALBMS-986504 + Nivolumab + Relatlimab FDC
Part 2: Cohort 4EXPERIMENTALBMS-986504 + Temozolomide + Radiotherapy
A phase II trial of BMS-986504 in patients with MTAP-deficient relapsed mesotheliomaEXPERIMENTAL -
Arm A: BMS-986504 + Pembrolizumab + ChemotherapyACTIVE_COMPARATOR -
Arm B: BMS-986504 + Pembrolizumab + ChemotherapyACTIVE_COMPARATOR -
Arm C: Placebo + Pembrolizumab + ChemotherapyPLACEBO_COMPARATOR -
Arm D: Placebo + Pembrolizumab + ChemotherapyPLACEBO_COMPARATOR -
Arm E: BMS-986504 + Pembrolizumab + ChemotherapyACTIVE_COMPARATOR -
Arm F: Placebo + Pembrolizumab + ChemotherapyPLACEBO_COMPARATOR -
Arm AEXPERIMENTAL -
Arm BEXPERIMENTAL -
Arm CPLACEBO_COMPARATOR -
Arm DPLACEBO_COMPARATOR -
Arm EEXPERIMENTAL -
Arm FPLACEBO_COMPARATOR -
Arm A: BMS-986504 Dose 1EXPERIMENTAL -
Arm B: BMS-986504 Dose 2EXPERIMENTAL -
Arm C: BMS-986504 Dose 1 + Izalontamab BrengitecanEXPERIMENTAL -
Arm D: BMS-986504 Dose 2 + Izalontamab BrengitecanEXPERIMENTAL -
BMS-986504 ArmEXPERIMENTAL -
[14C]-BMS-986504 followed by BMS-986504 MonotherapyEXPERIMENTALPart A: Participants will receive a single oral dose of radiolabeled \[14C\]-BMS-986504 on C1D1. Part B: Participants will receive non-radiolabeled BMS-986504, starting from C1D1 and until criteria for treatment discontinuation are met.
Phase 1/1BEXPERIMENTALDose Escalation/Evaluation
Phase 1b Sub-studies 1-4EXPERIMENTAL -
Phase 1b Sub-study 5EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986504DRUGSpecified dose on specified days
DaraxonrasibDRUGSpecified dose on specified days
Nivolumab + Relatlimab FDCDRUGSpecified dose on specified days
TemozolomideDRUGSpecified dose on specified days
PumitamigDRUGSpecified dose on specified days
PemetrexedDRUGSpecified dose on specified days
CarboplatinDRUGSpecified dose on specified days
Nab-paclitaxelDRUGSpecified dose on specified days
GemcitabineDRUGSpecified dose on specified days
PaclitaxelDRUGSpecified dose on specified days
PembrolizumabDRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
CisplatinDRUGSpecified dose on specified days
NavlimetostatDRUGSpecified dose on specified days
Izalontamab BrengitecanDRUGSpecified dose on specified days
[14C]-BMS-986504DRUGSpecified dose on specified days
MRTX1719DRUGMRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites58

Inclusion Criteria: * Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue. * Depending on the cohort enrolled, participants must have received standard therapies appropriate ...

Countries:United StatesBelgiumCanadaChinaFranceGermanyHong KongIrelandItalyJapanNorwaySouth KoreaSpainUnited KingdomArgentinaAustraliaAustriaBrazilBulgariaChileColombiaCzechiaDenmarkGreeceHungaryIndiaIsraelMalaysiaMexicoNetherlandsPolandRomaniaSwedenTaiwanThailandTurkey (Türkiye)SingaporeSlovakiaSouth AfricaSwitzerland
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Recent Changes (Last 90 Days)

LOWOct 6, 2026NCT07492680lastUpdatePostDate: changed
LOWOct 6, 2026NCT07492680lastUpdatePostDate: changed
LOWSep 23, 2026NCT07063745lastUpdatePostDate: changed
LOWSep 23, 2026NCT07063745lastUpdatePostDate: changed
MEDIUMSep 19, 2026NCT06855771Enrollment: 130 → 182
MEDIUMSep 19, 2026NCT06855771Enrollment: 130 → 182
MEDIUMSep 19, 2026NCT06855771Enrollment: 130 → 182
LOWSep 16, 2026NCT07492680lastUpdatePostDate: changed
LOWSep 16, 2026NCT07492680lastUpdatePostDate: changed
LOWSep 15, 2026NCT07063745lastUpdatePostDate: changed
LOWSep 15, 2026NCT07063745lastUpdatePostDate: changed
LOWSep 15, 2026NCT07063745lastUpdatePostDate: changed
LOWSep 2, 2026NCT05245500lastUpdatePostDate: changed
LOWSep 2, 2026NCT05245500lastUpdatePostDate: changed
LOWSep 2, 2026NCT05245500lastUpdatePostDate: changed
LOWAug 25, 2026NCT07492680lastUpdatePostDate: changed
LOWAug 25, 2026NCT07063745lastUpdatePostDate: changed
LOWAug 25, 2026NCT07492680lastUpdatePostDate: changed
LOWAug 25, 2026NCT07063745lastUpdatePostDate: changed
LOWAug 11, 2026NCT07063745lastUpdatePostDate: changed

Frequently asked questions about Navlimetostat

What is Navlimetostat?

Navlimetostat is an investigational small molecule oncology drug developed by Bristol-Myers Squibb Company (ticker: BMY). It is being studied in advanced solid tumors, including cancers with homozygous MTAP deletion, non-small cell lung cancer, mesothelioma, and pancreatic ductal adenocarcinoma. It is not yet approved and remains in clinical development.

What is Navlimetostat used for in advanced solid tumors?

Navlimetostat is being studied for the treatment of advanced solid tumors, particularly those with homozygous MTAP deletion. It is also being evaluated in metastatic non-small cell lung cancer with MTAP deletion, relapsed malignant mesothelioma, and untreated metastatic pancreatic ductal adenocarcinoma with homozygous MTAP deletion. It is investigational and not approved for any indication.

What does Navlimetostat target?

Navlimetostat is a small molecule that targets an enzyme in the -stat class. Its development focuses on tumors with homozygous MTAP deletion, a biomarker-selected population. The drug is designed to act on this enzyme target, and trials are enrolling patients whose tumors carry the MTAP deletion biomarker.

Who makes Navlimetostat?

Navlimetostat is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. Bristol-Myers Squibb is the sponsor of the clinical trials evaluating the drug in advanced solid tumors, mesothelioma, and pancreatic ductal adenocarcinoma.

What phase is Navlimetostat in?

Navlimetostat is in Phase 1 and Phase 2 clinical development. It is investigational and has not been approved by the FDA or any regulatory authority. The trials include Phase 1 and Phase 2 studies, with one active trial and others recruiting or not yet recruiting.

What clinical trials is Navlimetostat in?

Navlimetostat is being evaluated in several clinical trials. NCT07492680 is a recruiting Phase 2 study in advanced solid tumors with homozygous MTAP deletion. NCT07077434 is a recruiting Phase 1 study in advanced solid tumors. NCT07076121 is an active Phase 2 study in metastatic pancreatic ductal adenocarcinoma, and NCT07602946 is a Phase 2 study in relapsed mesothelioma.

Is Navlimetostat the same as BMS-986504 or MRTX1719?

Yes, Navlimetostat is also known as BMS-986504 and MRTX1719. These names refer to the same investigational drug developed by Bristol-Myers Squibb. The trials listed use the name BMS-986504 in their titles, while Navlimetostat is the current drug name.

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