Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

NCT05245500 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: CA240-00071719-001
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 25

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Number of Patients who Experience Dose-Limiting Toxicity

  21 days

• Number of patients who experience a treatment-related adverse event

  Up to 2 years

• Objective response rate (ORR)

  2 years

• Duration of response (DOR)

  2 years

• Progression free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

• Number of Patients With Clinically Significant Laboratory Assessments

  Up to 4 years

Secondary Outcomes (6)

• Area under the plasma concentration versus time curve (AUC)

  Up to 4 days

• Time to achieve maximal plasma concentration (Tmax)

  Up to 4 days

• Maximum observed plasma concentration (Cmax)

  Up to 4 days

• Terminal elimination half-life (t1/2)

  Up to 4 days

• Apparent total plasma clearance when dosed orally (CL/F)

  Up to 4 days

Study Arms (3)

Phase 1/1B

EXPERIMENTAL

Dose Escalation/Evaluation

Drug: MRTX1719

Phase 1b Sub-studies 1-4

EXPERIMENTAL

Drug: MRTX1719

Phase 1b Sub-study 5

EXPERIMENTAL

Drug: MRTX1719

Interventions

MRTX1719 DRUG

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

Phase 1/1B; Phase 1b Sub-studies 1-4; Phase 1b Sub-study 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (25)

Mayo Clinic

Phoenix, Arizona, 85054-4502, United States

RECRUITING

Sarah Cannon Research Institute (SCRI) - HealthONE Location

Denver, Colorado, 80218-1238, United States

RECRUITING

Rocky Mountain Cancer Centers, LLP - Oncology

Lone Tree, Colorado, 80124, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827, United States

RECRUITING

Local Institution - 124

Chicago, Illinois, 60637, United States

WITHDRAWN

Dana-Farber Cancer Institute

Brookline, Massachusetts, 02251, United States

RECRUITING

Cancer and Hematology Centers of Western Michigan

Norton Shores, Michigan, 49444, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

Local Institution - 129

Mineola, New York, 11501, United States

NOT YET RECRUITING

David H Koch, Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

New york cancer and blood specialists - Oncology

Port Jefferson Station, New York, 11776, United States

RECRUITING

New york cancer and blood specialists - Oncology

Port Jefferson Station, New York, 11776, United States

RECRUITING

University of North Carolina - Gastroenterology and Hepatology

Chapel Hill, North Carolina, 27599, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, 37232-5505, United States

RECRUITING

Ut Southwestern

Dallas, Texas, 75235, United States

RECRUITING

Texas Oncology - DFW

Fort Worth, Texas, 76104, United States

RECRUITING

MDACC

Houston, Texas, 77030, United States

RECRUITING

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

RECRUITING

Texas Oncology, P.A. - Oncology

Tyler, Texas, 78503, United States

RECRUITING

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

RECRUITING

Local Institution - 134

Seattle, Washington, 98109, United States

WITHDRAWN

Local Institution - 108

Milwaukee, Wisconsin, 53226, United States

COMPLETED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Mesothelioma; Carcinoma, Non-Small-Cell Lung; Neurofibrosarcoma; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Fibrosarcoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 18, 2022
• Study Start: June 9, 2022
• Primary Completion (Estimated): December 10, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (25)