Navlimetostat for MTAP-deleted solid tumors: monotherapy and combination therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label Phase 2 trial evaluating Navlimetostat (BMS-986504) in patients with MTAP-deleted advanced or metastatic solid tumors. It includes a monotherapy dose-expansion portion and a combination-dose escalation portion with partner anticancer agents. The study will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity both alone and in combination. Additional cohorts may be opened as data emerges to explore other regimens. Overall, the trial aims to identify feasible dosing and potential signals of benefit in this genetic subset.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene or MTAP loss detected in tumor tissue.
* Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.
* Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline and Radiologic assessment in neuro-oncology (RANO)2.0 as applicable at baseline.
* Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; or ≤ 2 x ULN in subjects with liver metastasis or liver cancer.
* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.
* Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
* Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.
* Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.
* Participants must not have active viral HBV or HCV hepatitis.
* Other protocol defined inclusion/exclusion criteria applies.

Where it's running

• Emory University - Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting
• Laura and Isaac Perlmutter Cancer Center at NYU Langone
  New York, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• UZ Brussel
  Brussels, Bruxelles-Capitale, Région de, Belgium Recruiting

+8 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.