Recruiting at 35 sites Phase 2 Solid Tumors

Clinical trial for Solid Tumors

Official title A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)

ClinicalTrials.gov ID: NCT07492680

What this study is testing

What is Navlimetostat?

Navlimetostat is an investigational medicine, being studied as a potential treatment for solid tumors.

Also referred to as MRTX1719, BMS-986504.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study aims to find out if the drug is safe and if it helps shrink tumors when used alone or with other cancer treatments.
Who it's for
The study is looking for people with advanced or metastatic solid tumors that have a specific genetic change known as MTAP deletion.
What's involved
Participants will receive BMS-986504 either by itself or combined with other anti-cancer drugs, along with regular medical tests to monitor safety and how the body processes the drug.
Time commitment
The source text does not specify the total duration of the study or the exact number of visits required.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP...
  • Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease...
  • Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline and Radiologic assessment in...
  • Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You likely can't join if

  • 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 must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including...
  • 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.

The study team makes the final eligibility decision.

Where it is enrolling

  • Atlanta, Georgia, United States
  • Baltimore, Maryland, United States
  • New York, New York, United States
  • Houston, Texas, United States
  • Brussels, Bruxelles-Capitale, Région de, Belgium
  • Ghent, Oost-Vlaanderen, Belgium
  • Chongqing, Chongqing Municipality, China
  • Xinxiang, Henan, China
  • Shanghai, Shanghai Municipality, China
  • Dijon, Côte-d'Or, France
  • Paris, France
  • Hamburg, Germany
  • Leipzig, Germany
  • Mainz, Germany
  • München, Germany
  • Würzburg, Germany
  • Cork, Ireland
  • Dublin, Ireland
  • Siena, Tuscany, Italy
  • Bergamo, Italy

+ 10 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Atlanta, Georgia, United States; Baltimore, Maryland, United States; New York, New York, United States; Houston, Texas, United States; Brussels, Bruxelles-Capitale, Région de, Belgium; Ghent, Oost-Vlaanderen, Belgium and 24 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.