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Protocol No. UW18121

Principal Investigator Leal, Ticiana

Phase I/II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation

Objective The main purpose of this study is to determine how much MRTX849 can safely be administered to people. This will include looking at what side effects occur and how often they occur. Other objectives of the study include assessing how quickly MRTX849 is absorbed into the blood stream and how fast it is removed by the body. The clinical activity of MRTX849 on your cancer will also be evaluated. Several laboratory tests will be performed using samples of tumor tissue or blood to understand how and why the drug may work

Treatment MRTX849 capsules are to be taken by mouth. At the start of the study, MRX849 will be taken once every day. Study treatment is divided into cycles; each cycle is 21 days in length. Based on observations in the study, the daily regimen may be adjusted to insert periods of rest or use multiple doses each day. Your study doctor will tell you how much and how often you should take study drug

Description Phase I/II Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation

Key Eligibility
  • Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
  • Unresectable or metastatic disease
  • Available and prior therapy: no available treatment with curative intent, no available standard-of-care treatment or patient is ineligible or declines treatment, except in Phase 2 NSCLC cohorts, patients must have previously received treatment with at least a platinum-containing chemotherapy regimen and checkpoint inhibitor therapy
  • Presence of tumor lesions to be evaluated per RECIST 1.1: Phase 1, Phase 1b cohorts that do not include a statistical evaluation of clinical activity, and cohort sub-studies, patients must have measurable or evaluable disease and Phase 1b cohorts that include a statistical evaluation of clinical activity and Phase 2, patients must have measurable disease
  • Must be 18 years of age or older and have a life expectancy of at least 3 months
  • Most recent prior systemic therapy (e.g., chemotherapy, immunotherapy or, investigational agent) and radiation therapy discontinued at least 2 weeks before first dose date
  • Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1
  • Adequate hematological, renal and hepatic function as defined by the protocol
  • Male and Female of child bearing potential must agree to adequate birth control as defined by the protocol
    EXCLUSION
  • Active brain metastases. Patients are eligible if brain metastases are adequately treated and patients are neurologically stable (except for residual signs or symptoms related to the central nervous system (CNS) treatment) for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent)
  • Patients with carcinomatous meningitis
  • History of significant hemoptysis or hemorrhage within 4 weeks of the first dose date
  • History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications
  • Any of the following cardiac abnormalities within the last 6 months: Unstable angina pectoris, congestive heart failure greater than or equal to NYHA Class 3, c. QTc greater than 480 milliseconds or family history of Long QT Syndrome
  • History of stroke or transient ischemic attack within the previous 6 months
  • Known human immunodeficiency virus (HIV) seropositivity or active Hepatitis B or C. Patients treated for hepatitis C with no detectable viral load are permitted
  • Can not be pregnant or breastfeeding

  • Applicable Disease Sites Colon and Rectum; Lung

    Status Open

    Participating Institutions UW Hospital and Clinics