A Study to Assess Safety, Tolerability and Drug Levels of Navlimetostat (BMS-986504) in Participa… (NCT07077434) | Clinical Trial Compass
RecruitingPhase 1
A Study to Assess Safety, Tolerability and Drug Levels of Navlimetostat (BMS-986504) in Participants With Advanced Solid Tumors
China, Japan32 participantsStarted 2025-10-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Plasma Concentration (Cmax) of BMS-986504
Timeframe: Up to approximately Day 64
2
Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504
Timeframe: Up to approximately Day 64
3
Area Under Curve (AUC) of BMS-986504
Timeframe: Up to approximately Day 64
4
Mean Elimination Half-life (T-HALF) of BMS-986504
Timeframe: Up to approximately Day 64
5
Apparent Total Body Clearance (CLT/F) of BMS-986504
Timeframe: Up to approximately Day 64
6
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BMS-986504
Timeframe: Up to approximately Day 64
Trial details
NCT IDNCT07077434
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-01-19
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com