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

Published: February 25, 2022

Primary Outcome Measures

  1. Phase 1: Number of Patients who Experience Dose-Limiting Toxicity [ Time Frame: 21 days ]
  2. Phase 1/1B: Number of patients who experience a treatment-related adverse event [ Time Frame: Up to 2 years ]
  3. Phase 2: Objective response rate (ORR) [ Time Frame: 2 years ]
  4. Phase 2: Duration of response (DOR) [ Time Frame: 2 years ]
  5. Phase 2: Progression free survival (PFS) [ Time Frame: 2 years ]
  6. Phase 2: Overall survival (OS) [ Time Frame: 2 years ]

Secondary Outcome Measures

  1. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Up to 4 days ]
  2. Time to achieve maximal plasma concentration (Tmax) [ Time Frame: Up to 4 days ]
  3. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 4 days ]
  4. Terminal elimination half-life (t1/2) [ Time Frame: Up to 4 days ]
  5. Apparent total plasma clearance when dosed orally (CL/F) [ Time Frame: Up to 4 days ]
  6. Apparent volume of distribution when dosed orally (Vz/F) [ Time Frame: Up to 4 days ]

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 (Phase 2 only).
  • 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
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