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Recruiting

Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion - CA240-0007

Updated: 16 August, 2024   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 21

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Phase 1/1B
Drug: MRTX1719
Experimental: Phase 1b Sub-Study
Drug: MRTX1719
Experimental: Phase 2
Drug: MRTX1719

Key Eligibility Criteria

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.

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466-DK-2200001