M.D. Anderson Cancer Center
To find the recommended dose of ulixertinib that can be given in combination with cetuximab and/or encorafenib to patients with unresectable/metastatic CRC and who have received EGFR or BRAF-directed therapy in the past.
Primary Objective: The primary objective is to establish the safety, maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of small molecule inhibitor ulixertinib when combined with EGFR inhibitor cetuximab. Primary Endpoints: 1. MTD based on number of dose-limiting toxicities (DLTs) 2. RP2D based on MTD Secondary Objectives: 1. To evaluate the safety and efficacy of ulixertinib in combination with cetuximab +/- encorafenib 2. Safety profile per CTCAE v5.0, including term, incidence, severity, and duration of AEs 3. Overall response rate (ORR) and Duration of response (DOR),…
Inclusion Criteria: Patients must meet all of the inclusion criteria to be eligible: 1. Provision of signed Informed Consent prior to any screening procedures being performed. 1. Non-English speaking patients will be eligible for participation with involvement of the MD Anderson Language Assistance department in the informed consent process (per MD Anderson SOP 04\_Informed Consent Process). 2. Individuals lacking the ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of participation in this study will not be eligible for participa…
Given by IV (vein)
Given by PO
Given by PO
Arctuva estimate
Verify or correct the compensation shown for this listing.