Drug: |
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Trial Name: |
Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion |
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NCT#: |
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Conditions: |
Solid Tumors |
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Status: |
Recruiting |
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Phase: |
1/2 |
Start Date 06/09/2022 |
Age of Trial (yrs) 2.8 |
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Treatment Phase: |
Gleevec-resistant |
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Drug Category: |
PRMT5 Inhibitor |
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Strategy: |
Selective inhibitor of PRMT5 |
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Trial Type: |
GIST not specified. GIST patient enrollment unknown. |
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Other Protocol IDs: |
CA240-0007
1719-001 |
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Sponsor: |
Mirati Therapeutics Inc. |
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Patient Contact: |
BMS Clinical Trials Contact Center
www.BMSClinicalTrials.com
Phone Number: 855-907-3286
Email: Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #. |
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Contact email: |
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Contact Phone: |
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Randomized: |
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IV or Oral: |
Oral |
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Trial Notes: |
Study Overview Brief Summary 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. 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 to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX1719. Eligibility Criteria Description 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. 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. Other protocol-defined Inclusion/Exclusion criteria apply. |
Trial Links |
Trial Results |
Drug Information |
Cancer Discovery 11/1/2023 MRTX1719 Is an MTA-Cooperative PRMT5 Inhibitor That Exhibits Synthetic Lethality in Preclinical Models and Patients with MTAP-Deleted Cancer |
Name |
Address |
City |
State |
Zip |
Country |
450 Brookline Ave |
Boston |
MA |
02215-5450 |
USA |
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1275 York Ave |
New York |
NY |
10065 |
USA |
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Phoenix |
AZ |
85054 |
USA |
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Jacksonville |
FL |
32224 |
USA |
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Rochester |
MN |
55905 |
USA |
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1505 Holcombe Blvd. |
Houston |
TX |
77030 |
USA |
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4319 Medical Dr. |
San Antonio |
TX |
78229 |
USA |
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Fairfax |
VA |
22031 |
USA |
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8701 Watertown Plank Rd. |
Milwaukee |
WI |
53226 |
USA |
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3322 West End Avenue |
Nashville |
TN |
37203 |
USA |