A Master Protocol for the Multi-Cohort Phase 1/2 Study of DCC-3116 in Combination with Anticancer Therapies in Participants with Advanced Malignancies

Are you eligible to participate in this study?

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

  • Conditions:
    Advanced Malignancies
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Must have pathologically confirmed CRC with a documented mutation in BRAF V600E
    2. Eligible to receive cetuximab per locally approved label with regard to tumor RAS status
    3. Must have received at least 1 and not more than 2 lines of prior systemic therapy (the maintenance portion of a systemic therapy is not counted as a separate line of therapy) in the advanced or metastatic setting (relapse during adjuvant therapy or within 6 months of completion of adjuvant therapy will be considered metastatic disease)

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

    1. New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of study drug
    2. Systemic arterial thrombotic or embolic events, such as cerebrovascular accident (including ischemic attacks) or moderate hemoptysis within 6 months prior to the first dose of study drug
    3. Systemic venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events (eg, pulmonary embolism) within 3 months prior to the start of study drug or requirement of anticoagulation therapy that cannot be interrupted at acceptable risk

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