Solid Tumor Clinical Trial
Official title:
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion
This is a Phase 1/2, 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.
Status | Recruiting |
Enrollment | 370 |
Est. completion date | April 30, 2026 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue or ctDNA - Unresectable or metastatic disease. - Patients must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment. 1. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease 2. Phase 1b and Phase 2 cohorts, RECIST 1.1 measurable 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Brookline | Massachusetts |
United States | Local Institution - 125 | Chapel Hill | North Carolina |
United States | Local Institution - 124 | Chicago | Illinois |
United States | Local Institution - 111 | Dallas | Texas |
United States | Local Institution - 120 | Dallas | Texas |
United States | Sarah Cannon Research Institute (SCRI) - HealthONE Location | Denver | Colorado |
United States | Virginia Cancer Specialists, PC | Fairfax | Virginia |
United States | MDACC | Houston | Texas |
United States | Oncology Consultants - Clinical Research | Houston | Texas |
United States | Mayo Clinic | Jacksonville | Florida |
United States | Local Institution - 109 | Lone Tree | Colorado |
United States | Medical College of Wisconsin - Froedtert Hospital | Milwaukee | Wisconsin |
United States | SCRI | Nashville | Tennessee |
United States | Local Institution - 127 | New Brunswick | New Jersey |
United States | David H Koch, Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Sarah Cannon Research Institute at Florida Cancer Specialists | Orlando | Florida |
United States | Mayo Clinic | Phoenix | Arizona |
United States | New york cancer and blood specialists - Oncology | Port Jefferson Station | New York |
United States | Mayo Clinic | Rochester | Minnesota |
United States | South Texas Accelerated Research Therapeutics | San Antonio | Texas |
United States | Local Institution - 110 | Tyler | Texas |
Lead Sponsor | Collaborator |
---|---|
Mirati Therapeutics Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1: Number of Patients who Experience Dose-Limiting Toxicity | 21 days | ||
Primary | Phase 1/1B: Number of patients who experience a treatment-related adverse event | Up to 2 years | ||
Primary | Phase 2: Objective response rate (ORR) | 2 years | ||
Primary | Phase 2: Duration of response (DOR) | 2 years | ||
Primary | Phase 2: Progression free survival (PFS) | 2 years | ||
Primary | Phase 2: Overall survival (OS) | 2 years | ||
Secondary | Area under the plasma concentration versus time curve (AUC) | Up to 4 days | ||
Secondary | Time to achieve maximal plasma concentration (Tmax) | Up to 4 days | ||
Secondary | Maximum observed plasma concentration (Cmax) | Up to 4 days | ||
Secondary | Terminal elimination half-life (t1/2) | Up to 4 days | ||
Secondary | Apparent total plasma clearance when dosed orally (CL/F) | Up to 4 days | ||
Secondary | Apparent volume of distribution when dosed orally (Vz/F) | Up to 4 days |
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