Advanced Solid TumorsPhase 1NCT07077434
A Study to Assess Safety, Tolerability and Drug Levels of Navlimetostat (BMS-986504) in Participants With Advanced Solid Tumors
A Phase 1 study testing BMS-986504 in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 12 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and drug levels of Navlimetostat (BMS-986504) in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BMS-986504
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 15 Oct 2025to 19 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically confirmed diagnosis of a solid tumor malignancy with homozygous MTAP deletion or MTAP loss detected in tumor tissue by a Sponsor-provided central test or a Sponsor pre-approved local test.
- Participants must have unresectable or metastatic disease not amenable to curative therapies after progression on prior therapies at the time of enrollment.
- Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants must have presence of at least one measurable tumor lesion per RECIST 1.1 at baseline.
Who cannot join
- Participants must not have prior treatment with a Protein arginine methyltransferase 5 (PRMT5) or Methionine adenosyltransferase 2A (MAT2A) inhibitor.
- Participants must not have active brain metastases or carcinomatous meningitis.
- Participants must not have a history of gastrointestinal disease or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
- Participants must not have known severe hypersensitivity to study treatment and/or any of its excipients.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com contact
First line of the email MUST contain NCT # and Site #. contact
12 sites in 2 countries
China8 sites, 8 recruiting
- Recruiting
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142
lin shen, Site 0001, 8601088196340
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Jing Lin, Site 0002, 8613225999969
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
Jian Xiao, Site 0010, +8613711114566
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yanqiao Zhang, Site 0006, 13845120210
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Yuping Sun, Site 0007, 13370582181
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
shubin wang, Site 0009, 13823394076
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Xiuchao Wang, Site 0012, 13752038814
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
Yinghua Ji, Site 0011, 13663030446
Japan4 sites, 4 recruiting
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Jun Sato, Site 0005, +81-3-3542-2511
- Recruiting
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Shigehisa Kitano, Site 0004, +81-3-3520-0111
- Recruiting
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777
Ryo Ko, Site 0008, +81-55-989-5222
- Recruiting
Kanagawa cancer center
Yokohama, Kanagawa, 2418515
Makoto Ueno, Site 0003, +81-45-520-2222
About this study
Official title: A Phase 1 Open-Label, Multi-Center Study to Evaluate Pharmacokinetics, Safety and Tolerability of Navlimetostat (BMS-986504) in Japanese and Chinese Participants With Advanced Solid Tumors With Homozygous MTAP Deletion
The purpose of this study is to evaluate the safety, tolerability and drug levels of Navlimetostat (BMS-986504) in participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- BMS-986504
- Keywords
- MTAP, PRMT5, MRTX1719, CDKN2A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986504Drug
Also called MRTX1719
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986504 Arm | Experimental | Not described Receives: Drug: BMS-986504 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of BMS-986504
Measured: Up to approximately Day 64
Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504
Measured: Up to approximately Day 64
Area Under Curve (AUC) of BMS-986504
Measured: Up to approximately Day 64
Mean Elimination Half-life (T-HALF) of BMS-986504
Measured: Up to approximately Day 64
Apparent Total Body Clearance (CLT/F) of BMS-986504
Measured: Up to approximately Day 64
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BMS-986504
Measured: Up to approximately Day 64
Secondary outcomes (10)
Number of Participants With Dose-limiting Toxicities (DLTs)
Measured: Up to approximately Day 25
Number of Participants With Treatment-related Adverse Events (AE)
Measured: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With all-cause AEs
Measured: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With Treatment-related Serious AEs (SAEs)
Measured: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With all-cause SAEs
Measured: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With AEs Leading to Dose Interruption
Measured: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With AEs Leading to Dose Reduction
Measured: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With AEs Leading to Treatment Discontinuation
Measured: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With AEs Leading to Death
Measured: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With Laboratory Abnormalities
Measured: Up to approximately 28 days after last dose of BMS-986504
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start15 Oct 2025
- Primary completion19 Jan 2027 (estimated)
- Study completion19 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077434
- Sponsor's protocol ID
- CA240-0010
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Multi-Center Study to Evaluate Pharmacokinetics, Safety and Tolerability of Navlimetostat (BMS-986504) in Japanese and Chinese Participants With Advanced Solid Tumors With Homozygous MTAP Deletion
- ClinicalTrials.gov ID
- NCT07077434
- Acronym / sponsor ID
- CA240-0010
- Conditions
- Advanced Solid Tumors
- Keywords
- MTAP, PRMT5, MRTX1719, CDKN2A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 19 Jan 2027 (estimated)
- Study completion
- 19 Jan 2027 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and drug levels of Navlimetostat (BMS-986504) in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986504 Arm | Experimental | Drug: BMS-986504 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have histologically confirmed diagnosis of a solid tumor malignancy with homozygous MTAP deletion or MTAP loss detected in tumor tissue by a Sponsor-provided central test or a Sponsor pre-approved local test.
- Participants must have unresectable or metastatic disease not amenable to curative therapies after progression on prior therapies at the time of enrollment.
- Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants must have presence of at least one measurable tumor lesion per RECIST 1.1 at baseline.
Key exclusion criteria (5 listed)
- Participants must not have prior treatment with a Protein arginine methyltransferase 5 (PRMT5) or Methionine adenosyltransferase 2A (MAT2A) inhibitor.
- Participants must not have active brain metastases or carcinomatous meningitis.
- Participants must not have a history of gastrointestinal disease or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
- Participants must not have known severe hypersensitivity to study treatment and/or any of its excipients.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986504Also: MRTX1719Specified dose on specified days | Drug | BMS-986504 Arm |
Primary outcome
Maximum Plasma Concentration (Cmax) of BMS-986504
Time frame: Up to approximately Day 64
Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504
Time frame: Up to approximately Day 64
Area Under Curve (AUC) of BMS-986504
Time frame: Up to approximately Day 64
Mean Elimination Half-life (T-HALF) of BMS-986504
Time frame: Up to approximately Day 64
Apparent Total Body Clearance (CLT/F) of BMS-986504
Time frame: Up to approximately Day 64
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BMS-986504
Time frame: Up to approximately Day 64
10 secondary outcomes
Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: Up to approximately Day 25
Number of Participants With Treatment-related Adverse Events (AE)
Time frame: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With all-cause AEs
Time frame: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With Treatment-related Serious AEs (SAEs)
Time frame: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With all-cause SAEs
Time frame: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With AEs Leading to Dose Interruption
Time frame: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With AEs Leading to Dose Reduction
Time frame: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With AEs Leading to Treatment Discontinuation
Time frame: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With AEs Leading to Death
Time frame: Up to approximately 28 days after last dose of BMS-986504
Number of Participants With Laboratory Abnormalities
Time frame: Up to approximately 28 days after last dose of BMS-986504
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986504 in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of BMS-986504 (time frame: Up to approximately Day 64). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.