Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369259
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-04-12
Brief Title:
Open-label Phase 2 Study of Avutometinib RAFMEK Clamp in Combination With Defactinib FAK Inhibitor and Cetuximab in Patients With Unresectable Anti-EGFR-Refractory Advanced Colorectal Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Open-label Phase 2 Study of Avutometinib RAFMEK Clamp in Combination With Defactinib FAK Inhibitor and Cetuximab in Patients With Unresectable Anti-EGFR-Refractory Advanced Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 11
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03302 | OTHER | NCI-CTRP Clinical Registry | None |