Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

Phase 1

Recruiting

• Conditions: Pancreatic Adenocarcinoma; Non Small Cell Lung Cancer; Advanced Solid Tumor; Malignant Peripheral Nerve Sheath Tumors; Mesothelioma; Solid Tumor
• Interventions: Drug: MRTX1719

• Registration Number: NCT05245500
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-14
• Study First Posted: 2022-02-18
• Study Start: 2022-06-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1/1B	MRTX1719	Dose Escalation/Evaluation
Phase 1b Sub-Study	MRTX1719	MRTX1719 in combination with standard of care therapy in selected solid tumor malignancies with MTAP homozygous deletion

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Terminal elimination half-life (t1/2)	Up to 4 days
Time to achieve maximal plasma concentration (Tmax)	Up to 4 days
Area under the plasma concentration versus time curve (AUC)	Up to 4 days
Maximum observed plasma concentration (Cmax)	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

Trial Locations

Locations (22)

Rocky Mountain Cancer Centers, LLP - Oncology; 🇺🇸 Lone Tree, Colorado, United States

Cancer and Hematology Centers of Western Michigan; 🇺🇸 Norton Shores, Michigan, United States

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Local Institution - 132; 🇺🇸 Nashville, Tennessee, United States

Texas Oncology - DFW; 🇺🇸 Fort Worth, Texas, United States

Texas Oncology, P.A. - Oncology; 🇺🇸 Tyler, Texas, United States

Local Institution - 134; 🇺🇸 Seattle, Washington, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Sarah Cannon Research Institute (SCRI) - HealthONE Location; 🇺🇸 Denver, Colorado, United States

Sarah Cannon Research Institute at Florida Cancer Specialists; 🇺🇸 Orlando, Florida, United States

Local Institution - 124; 🇺🇸 Chicago, Illinois, United States

Dana-Farber Cancer Institute; 🇺🇸 Brookline, Massachusetts, United States

David H Koch, Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

New york cancer and blood specialists - Oncology; 🇺🇸 Port Jefferson Station, New York, United States

Local Institution - 125; 🇺🇸 Chapel Hill, North Carolina, United States

SCRI; 🇺🇸 Nashville, Tennessee, United States

Local Institution - 120; 🇺🇸 Dallas, Texas, United States

MDACC; 🇺🇸 Houston, Texas, United States

Oncology Consultants - Clinical Research; 🇺🇸 Houston, Texas, United States

South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States

Virginia Cancer Specialists, PC; 🇺🇸 Fairfax, Virginia, United States

Medical College of Wisconsin - Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States