Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: 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

Study ID: NCT06369259

Conditions

Advanced Colorectal Cancer

Interventions

Defactinib

Cetuximab

Avutometinib

Study Description

Brief Summary: To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer.

Detailed 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 defactinib * Demonstrate feasibility of establishing patient-derived xenograft (PDX) models in matched patients with cetuximab-refractory mCRC to evaluate for biomarkers of response and mechanisms of resistance. * Explore mechanisms of resistance to cetuximab plus avutometinib and defactinib