Clinical trial · Interventional
A Study to Assess Safety, Tolerability and Drug Levels of Navlimetostat (BMS-986504) in Participants With Advanced Solid Tumors
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
NCT07077434CI-TRIAL-00113462recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986504 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BMS-986504 Arm
- interventionNames
- Drug: BMS-986504
Primary outcomes (6)
- measure
- Maximum Plasma Concentration (Cmax) of BMS-986504
- timeFrame
- Up to approximately Day 64
- measure
- Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504
- timeFrame
- Up to approximately Day 64
- measure
- Area Under Curve (AUC) of BMS-986504
- timeFrame
- Up to approximately Day 64
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.