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Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

RecruitingPhase 1

A Phase 1 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria

* Histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.
* Unresectable or metastatic disease.
* Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible.
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function.

Exclusion Criteria

* Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
* Active brain metastases or carcinomatous meningitis.
* History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
* Major surgery within 4 weeks of first dose of study treatment.
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
* Cardiac abnormalities.
* Other protocol-defined Inclusion/Exclusion criteria apply.

About the study

This is a Phase 1, open-label, multicenter, study of the safety, tolerability, PK, PD, and anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene.

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 336 · Started: Jun 9, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05245500

Locations in the U.S.

ArizonaMayo Clinic, Phoenix
ColoradoRocky Mountain Cancer Centers, LLP - Oncology, Lone Tree
FloridaMayo Clinic, Jacksonville
Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando
MassachusettsDana-Farber Cancer Institute, Brookline
MichiganThe Cancer & Hematology Centers, Grand Rapids
Cancer and Hematology Centers of Western Michigan, Norton Shores
MinnesotaMayo Clinic, Rochester
New JerseyRutgers Cancer Institute of New Jersey, New Brunswick
New YorkPerlmutter Cancer Center at NYU Langone Hospital Long Island, Mineola
David H Koch, Memorial Sloan Kettering Cancer Center, New York
New york cancer and blood specialists - Oncology, Port Jefferson Station
New york cancer and blood specialists - Oncology, Port Jefferson Station
North CarolinaUniversity of North Carolina, Chapel Hill
University of North Carolina - Gastroenterology and Hepatology, Chapel Hill
TennesseeVanderbilt - Ingram Cancer Center, Nashville
TexasUt Southwestern, Dallas
Texas Oncology - DFW, Fort Worth
MDACC, Houston
South Texas Accelerated Research Therapeutics, San Antonio
Texas Oncology, P.A. - Oncology, Tyler
VirginiaVirginia Cancer Specialists, PC, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.