Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer
M.D. Anderson Cancer Center
Summary
To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer.
Description
The primary objective is to assess the antitumor activity of the treatment combinations based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary Objectives: 1. Assess impact of treatment combinations on survival 2. Characterize the safety profile of the treatment combinations (DLTs) 3. Evaluate the pharmacodynamics of the avutometinib combination with defactinib plus cetuximab. 4. Evaluate for pERK and Ki67 inhibition Exploratory Objectives * Assess blood- and tissue-based predictive biomarkers of activity upon treatment with cetuximab plus avutometinib plus de…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: • Provision of signed Informed Consent prior to any screening procedures being performed. * Non-English speaking participants 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). * 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 participation. * Age ≥ 18 years at the time of informed consent. * Histolog…
Interventions
- DrugDefactinib
Given by PO
- DrugCetuximab
Given by IV
- DrugAvutometinib
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas