Perlmutter Cancer Center

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Advanced Or Metastatic Solid Tumors With Ras/mapk Pathway Mutations
• Age: Between 18 years - 100 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  In order to participate in this study the following criteria must be met:

  1. Dose Escalation Phase (Part 1): a. Histologically confirmed diagnosis of an advanced or metastatic solid tumor with a documented RAS, NF1, or RAF mutations b. Have progressed despite standard therapies, or for whom conventional therapy is not considered effective or tolerable, as judged by the Investigator. Must have received at least 1 prior line of anticancer therapy and have a life expectancy of more than 3 months
  2. Dose Expansion Phase (Part 2): Have progressed despite standard therapies listed below, or for whom conventional therapy is not considered effective or tolerable, as judged by the Investigator a. Expansion Cohort 1: Patients with PDAC: - Must have histologically confirmed PDAC with a documented mutation in KRAS. A molecular pathology report documenting mutational status of KRAS must be available - Received only 1 prior line of systemic therapy in the advanced or metastatic setting and have a life expectancy of more than 3 months in the judgment of the Investigator.

  
  

You may not be eligible for this study if the following are true:

• You will not be able to participate in this study if you have had:

  1. Prior therapies (anticancer or therapies given for other reasons) that are known strong or moderate inhibitors or inducers of CYP3A4 or P-gp (refer to Section 9.8.3) including certain herbal medications (eg, St. John’s Wort): 14 days or 5× the half-life of the medication (whichever is longer).
  2. Investigational therapies with unknown safety and PK profile: 28 days. If there is enough data on the investigational therapy to assess the risk for drug-drug interactions and late toxicities of prior therapy as low, the Sponsor’s Medical Monitor may approve a shorter washout of 14 days.
  3. All other prior anticancer therapies or any therapy that is investigational for the participant’s condition with a known safety and PK profile: 14 days or 5× the half-life of the medication (whichever is shorter).