A Phase 2 interventional study of Navlimetostat and Daraxonrasib in Solid Tumors, sponsored by Bristol-Myers Squibb. Recruiting at 58 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
This is an open-label, multicenter Phase 2 study evaluating Navlimetostat (BMS-986504) in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which Navlimetostat (BMS-986504) is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Navlimetostat (BMS-986504) alone and in combination regimens.
Part 1 will include parallel enrolment of tumor-specific dose-expansion cohorts evaluating Navlimetostat (BMS-986504) as monotherapy. Part 2 will include dose-escalation cohorts in which Navlimetostat (BMS-986504) is given in combination with other anticancer agents. Additional cohorts may be added based on emerging data.
2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.
This study's planned enrollment of 254 is above the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 2, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
iRECIST and mRECIST
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Navlimetostat (BMS-986504)
Drug: Navlimetostat
Navlimetostat (BMS-986504)
Drug: Navlimetostat
Navlimetostat (BMS-986504) + Pumitamig + Chemotherapy
Drug: Navlimetostat · Drug: Pumitamig · Drug: Pemetrexed · Drug: Carboplatin · Drug: Nab-paclitaxel · Drug: Paclitaxel · Drug: Cisplatin
Navlimetostat (BMS-986504) + Daraxonrasib
Drug: Navlimetostat · Drug: Daraxonrasib
Navlimetostat (BMS-986504) + Daraxonrasib
Drug: Navlimetostat · Drug: Daraxonrasib
Navlimetostat (BMS-986504) + Daraxonrasib + Chemotherapy
Drug: Navlimetostat · Drug: Daraxonrasib · Drug: Nab-paclitaxel · Drug: Gemcitabine
Navlimetostat (BMS-986504) + Temozolomide + Radiotherapy
Drug: Navlimetostat · Drug: Temozolomide
Specified dose on specified days
Also known as: MRTX1719, BMS-986504
Specified dose on specified days
Also known as: RMC-6236
Specified dose on specified days
Specified dose on specified days
Also known as: BNT327, BMS-986545
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Also known as: Abraxane
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Part 1: Number of participants who achieve Objective Response (OR)
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
Time frame: Up to approximately 2 years
Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria
Time frame: Up to approximately 2 years
Part 2: Number of participants with adverse events (AE)
Time frame: Up to approximately 2 years
Part 2: Number of participants with Serious AEs (SAEs)
Time frame: Up to approximately 2 years
Part 2: Number of participants with treatment related AEs
Time frame: Up to approximately 2 years
Part 2: Number of participants with treatment related SAEs
Time frame: Up to approximately 2 years
Part 2: Number of participants with AEs leading to study treatment discontinuation
Time frame: Up to approximately 2 years
Part 2: Number of participants with AEs leading to death
Time frame: Up to approximately 2 years
Part 2: Number of participants with laboratory abnormalities
Time frame: Up to approximately 2 years
Part 1 and 2: Time to objective response (TTOR)
Defined as time from first dose to the date of the first documentation of objective tumor response (CR or PR) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1
Time frame: Up to approximately 2 years
Part 1 and 2: Duration of response (DOR)
Defined as the time between the date of the first documentation of objective tumor response (CR or PR) and the date of disease progression or to death from any cause (whichever occurs first) by RECIST v1.1. or RANO v2 or Modified RECIST v1.1
Time frame: Up to approximately 2 years
Part 1 and 2: Number of participants who achieve disease control (DC)
Best Overall Response (BOR) of confirmed CR, confirmed PR, or stable disease (SD) for at least 4 months after start of treatment) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1
Time frame: Up to approximately 2 years
Part 1: Number of participants with adverse events (AE)
Time frame: Up to approximately 2 years
Part 1: Number of participants with Serious AEs (SAEs)
Time frame: Up to approximately 2 years
Part 1: Number of participants with treatment related AEs
Time frame: Up to approximately 2 years
Part 1: Number of participants with treatment related SAEs
Time frame: Up to approximately 2 years
Part 1: Number of participants with AEs leading to study treatment discontinuation
Time frame: Up to approximately 2 years
Part 1: Number of participants with AEs leading to death
Time frame: Up to approximately 2 years
Part 1: Number of participants with laboratory abnormalities
Time frame: Up to approximately 2 years
Part 2: Number of participants who achieve Objective Response (OR)
Time frame: Up to approximately 2 years
Part 1 and 2: Number of participants who achieved clinical benefit (CB)
CB defined as BOR of confirmed CR, confirmed PR, or SD for at least 4 months after start of treatment by RECIST v1.1 or RANO v2
Time frame: Up to approximately 2 years
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Jul 2026 (actual). Primary completion is estimated for Aug 2028, 24 months after the start.
Of 44 industry-sponsored phase 2 interventional studies under Brain Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 55. This study's planned 24 months is below that.
Counting every sponsor, half of 252 studies reached it within 61 months; a quarter within 38 and three quarters within 98.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Navlimetostat