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Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

NCT ID: NCT05245500

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-09

Study Completion Date

2027-12-10

Brief Summary

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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.

Detailed Description

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This first-in-human clinical trial will begin with an exploration of MRTX1719 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure sufficient safety experience, PK information, compare food effect and relative bioavailability between capsules and tablets, and early evidence of clinical activity are available.

Conditions

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Mesothelioma Non Small Cell Lung Cancer Malignant Peripheral Nerve Sheath Tumors Solid Tumor Pancreatic Adenocarcinoma Advanced Solid Tumor

Keywords

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MTAP Deletion Mesothelioma Non Small Cell Lung Cancer Malignant Peripheral Nerve Sheath Tumors Solid Tumor MTAP Malignant Pancreatic adenocarcinoma Pancreas Cancer PRMT5 Synthetic Lethality Advanced Solid Tumor NSCLC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1/1B

Dose Escalation/Evaluation

Group Type EXPERIMENTAL

MRTX1719

Intervention Type DRUG

MRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days

Phase 1b Sub-studies 1-4

Group Type EXPERIMENTAL

MRTX1719

Intervention Type DRUG

MRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days

Phase 1b Sub-study 5

Group Type EXPERIMENTAL

MRTX1719

Intervention Type DRUG

MRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days

Interventions

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MRTX1719

MRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Mayo Clinic

Phoenix, Arizona, United States

Site Status RECRUITING

Sarah Cannon Research Institute (SCRI) - HealthONE Location

Denver, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers, LLP - Oncology

Lone Tree, Colorado, United States

Site Status RECRUITING

Mayo Clinic

Jacksonville, Florida, United States

Site Status RECRUITING

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, United States

Site Status RECRUITING

Local Institution - 124

Chicago, Illinois, United States

Site Status WITHDRAWN

Dana-Farber Cancer Institute

Brookline, Massachusetts, United States

Site Status RECRUITING

Cancer and Hematology Centers of Western Michigan

Norton Shores, Michigan, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status RECRUITING

David H Koch, Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

New york cancer and blood specialists - Oncology

Port Jefferson Station, New York, United States

Site Status RECRUITING

New york cancer and blood specialists - Oncology

Port Jefferson Station, New York, United States

Site Status RECRUITING

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, United States

Site Status RECRUITING

Ut Southwestern

Dallas, Texas, United States

Site Status RECRUITING

Texas Oncology - DFW

Fort Worth, Texas, United States

Site Status RECRUITING

Local Institution - 108

Houston, Texas, United States

Site Status COMPLETED

MDACC

Houston, Texas, United States

Site Status RECRUITING

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Site Status RECRUITING

Texas Oncology, P.A. - Oncology

Tyler, Texas, United States

Site Status RECRUITING

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Site Status RECRUITING

Local Institution - 134

Seattle, Washington, United States

Site Status WITHDRAWN

Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

Phone: 855-907-3286

Email: [email protected]

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

Role: CONTACT

Facility Contacts

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Tanios Bekaii-Saab, Site 113

Role: primary

Sreenivasa Chandana, Site 106

Role: primary

Robert Jotte, Site 109

Role: primary

Hani Babiker, Site 114

Role: primary

Cesar Perez Batista, Site 121

Role: primary

Pasi Janne, Site 103

Role: primary

Sreenivasa Chandana, Site 131

Role: primary

Lei Deng, Site 112

Role: primary

Kristen Spencer, Site 127

Role: primary

Kathryn Arbour, Site 104

Role: primary

Richard Zuniga, Site 101

Role: primary

Richard Zuniga, Site 115

Role: primary

Shetal Patel, Site 125

Role: primary

Elizabeth Davis, Site 132

Role: primary

Salwan Al Mutar, Site 120

Role: primary

Andrew Paulson, Site 111

Role: primary

Jordi Ahnert, Site 105

Role: primary

Kyriakos Papadopoulos, Site 102

Role: primary

Donald Richards, Site 110

Role: primary

Alexander Spira, Site 122

Role: primary

Shetal Patel, Site 107

Role: primary

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT05245500.html

BMS Clinical Trial Patient Recruiting

Other Identifiers

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CA240-0007

Identifier Type: OTHER

Identifier Source: secondary_id

1719-001

Identifier Type: OTHER

Identifier Source: secondary_id

CA240-0007

Identifier Type: -

Identifier Source: org_study_id

NCT06937970

Identifier Type: -

Identifier Source: nct_alias