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NCT Number: NCT07077434

A Study to Assess Safety, Tolerability and Drug Levels of Navlimetostat (BMS-986504) in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability and drug levels of Navlimetostat (BMS-986504) in participants with advanced solid tumors.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986504

Drug

Specified dose on specified days

Other names: MRTX1719

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of BMS-986504

    Time frame: Up to approximately Day 64

  2. Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504

    Time frame: Up to approximately Day 64

  3. Area Under Curve (AUC) of BMS-986504

    Time frame: Up to approximately Day 64

  4. Mean Elimination Half-life (T-HALF) of BMS-986504

    Time frame: Up to approximately Day 64

  5. Apparent Total Body Clearance (CLT/F) of BMS-986504

    Time frame: Up to approximately Day 64

  6. Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BMS-986504

    Time frame: Up to approximately Day 64

Secondary outcomes

  1. Number of Participants With Dose-limiting Toxicities (DLTs)

    Time frame: Up to approximately Day 25

  2. Number of Participants With Treatment-related Adverse Events (AE)

    Time frame: Up to approximately 28 days after last dose of BMS-986504

  3. Number of Participants With all-cause AEs

    Time frame: Up to approximately 28 days after last dose of BMS-986504

  4. Number of Participants With Treatment-related Serious AEs (SAEs)

    Time frame: Up to approximately 28 days after last dose of BMS-986504

  5. Number of Participants With all-cause SAEs

    Time frame: Up to approximately 28 days after last dose of BMS-986504

  6. Number of Participants With AEs Leading to Dose Interruption

    Time frame: Up to approximately 28 days after last dose of BMS-986504

  7. Number of Participants With AEs Leading to Dose Reduction

    Time frame: Up to approximately 28 days after last dose of BMS-986504

  8. Number of Participants With AEs Leading to Treatment Discontinuation

    Time frame: Up to approximately 28 days after last dose of BMS-986504

  9. Number of Participants With AEs Leading to Death

    Time frame: Up to approximately 28 days after last dose of BMS-986504

  10. Number of Participants With Laboratory Abnormalities

    Time frame: Up to approximately 28 days after last dose of BMS-986504

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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