Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion
- Conditions
- MesotheliomaNon Small Cell Lung CancerMalignant Peripheral Nerve Sheath TumorsSolid TumorPancreatic AdenocarcinomaAdvanced Solid Tumor
- Interventions
- Registration Number
- NCT06937970
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
Not provided
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 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
Trial Locations
- Locations (22)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Rocky Mountain Cancer Centers, LLP - Oncology
🇺🇸Lone Tree, Colorado, 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
Cancer and Hematology Centers of Western Michigan
🇺🇸Norton Shores, Michigan, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, 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 - 132
🇺🇸Nashville, Tennessee, United States
Local Institution - 120
🇺🇸Dallas, Texas, United States
Texas Oncology - DFW
🇺🇸Fort Worth, 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
Texas Oncology, P.A. - Oncology
🇺🇸Tyler, Texas, United States
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
Local Institution - 134
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin - Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States