Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-31 @ 1:24 AM
Study NCT ID:
NCT06369259
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2024-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-03302 | OTHER | NCI-CTRP Clinical Registry | View |