Phase 1 Study Of MRTX1719 In Solid Tumors With MTAP Deletion

Study Overview

Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

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.

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.

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

DRUG: MRTX1719

CA240-0007
CA240-0007 (OTHER Identifier) (OTHER: Bristol-Myers Squibb Protocol ID)
1719-001 (OTHER Identifier) (OTHER: Mirati Therapeutics Protocol ID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-02-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-02
First Submitted that Met QC Criteria 2022-02-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-06
First Posted (ACTUAL) 2022-02-18	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Phase 1/1B Dose Escalation/Evaluation	DRUG: MRTX1719 MRTX1719 is a potent PRMT5-MTA inhibitor Specified dose on specified days
EXPERIMENTAL: Phase 1b Sub-Study MRTX1719 in combination with standard of care therapy in selected solid tumor malignancies with MTAP homozygous deletion	DRUG: MRTX1719 MRTX1719 is a potent PRMT5-MTA inhibitor Specified dose on specified days

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Phase 1/1B

Dose Escalation/Evaluation

DRUG: MRTX1719

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

EXPERIMENTAL: Phase 1b Sub-Study

MRTX1719 in combination with standard of care therapy in selected solid tumor malignancies with MTAP homozygous deletion

DRUG: MRTX1719

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

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame
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
Apparent volume of distribution when dosed orally (Vz/F)		Up to 4 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Phone Number: 855-907-3286

Email: Clinical.Trials@bms.com

Study Contact Backup

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

Phone Number:

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record