Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT06369259
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
Study:
NCT06369259
Study Brief:
Protocol Section:
NCT06369259