Navlimetostat for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, Navlimetostat, to determine how the body absorbs it in two different tablet forms. The goal is to find out if one form is more effective than the other in healthy adult women. The trial targets women who feel healthy and have no major health issues or recent stomach or gut problems. As a Phase 1 trial, this research aims to understand how Navlimetostat works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants, it's likely that you should not be on any significant medications. Please check with the trial organizers for specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that navlimetostat was generally well-tolerated in earlier studies. Participants mostly experienced mild side effects, which were not serious and easy to manage. Navlimetostat has also shown promise in treating certain types of cancer, indicating its design aims to be effective while minimizing harm. Although ongoing research continues, current evidence suggests that navlimetostat is safe for humans at the doses tested so far.12345
Why are researchers excited about this trial's treatments?
Navlimetostat is unique because it introduces a new mechanism of action for treating various conditions. While most treatments work by directly targeting symptoms or specific pathways, Navlimetostat is designed to modulate specific biological processes at the molecular level, potentially offering a more precise approach. Researchers are excited about Navlimetostat because it could lead to more effective and targeted therapies with fewer side effects, representing a significant advancement over current options.
What evidence suggests that this trial's treatments could be effective?
Research has shown that Navlimetostat might help treat certain cancers. One study involved 179 patients taking Navlimetostat, with 94 assessed for effectiveness over six months. About 27% of these patients experienced a significant reduction in their cancer, suggesting that Navlimetostat could help control cancer growth. The drug blocks certain proteins that influence tumor growth and survival, potentially fighting cancer by altering cell behavior and growth. Participants in this trial will receive Navlimetostat in different experimental treatment arms to further evaluate its effects.12678
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for healthy adult women who are not of childbearing potential, have a BMI between 18 and 35, normal heart tests, and good kidney and liver function. Participants must not have any significant health issues as determined by the study doctor.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Navlimetostat in two different tablet formulations to assess bioequivalence
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Navlimetostat
Trial Overview
The study is testing two different tablet forms (wet-granulation vs dry-granulation) of Navlimetostat to see how the body processes each one. Only one group receives both types in a controlled setting.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
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Ph1/2 Trial Of Navlimetostat With Pumitamig In MTAP ...
The goal of this clinical research study is to find a safe and tolerable dose of navlimetostat in combination with pumitamig that can be given to patients …
Navlimetostat - Drug Targets, Indications, Patents
In total, 179 patients received the drug, 94 of whom were evaluable for efficacy with at least six months of follow-up. The ORR among the 94 patients was 27%, ...
Clinical Trial of BMS-986504 in Recurrent GBM Patients
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Safety, Tolerability, and Pharmacokinetics of Valemetostat ...
Valemetostat was well tolerated in healthy subjects; treatment‐emergent adverse events were mild (grade 1) in severity. Based on these trials, ...
Safety and pharmacokinetics of mevrometostat (M) in ...
In pts with mCRPC treated with M + E, M 875 mg with food had an improved safety profile compared with M 1250 mg on an empty stomach.
Safety, Tolerability, and Pharmacokinetics of Valemetostat ...
Valemetostat was well tolerated in healthy subjects; treatment-emergent adverse events were mild (grade 1) in severity. Based on these trials, ...
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