Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412198
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-09
Brief Title:
A Multicenter Phase 1b2 Study of Adagrasib Cetuximab and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Multicenter Phase 1b2 Study of Adagrasib Cetuximab and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if the drug combination of adagrasib cetuximab and cemiplimab can help to control metastatic CRC with KRAS G12C mutations
Detailed Description:
Primary Objective
To determine the objective response rate of the adagrasib cetuximab and cemiplimab combination for treatment of advanced KRAS G12C MT CRC that has progressed on at least one line of prior systemic chemotherapy
Secondary Objectives
To estimate duration of response DOR progression free survival PFS and overall survival OS for the combination of adagrasib cetuximab and cemiplimab in participants with advanced KRAS G12C MT CRC that has progressed on at least one line of prior systemic chemotherapy
To estimate the safety and tolerability of the combination of adagrasib cetuximab and cemiplimab in participants with advanced KRAS G12C MT CRC that has progressed on at least one line of prior systemic chemotherapy
Exploratory Objectives
To assess predictive biomarkers of response and resistance to the combination of adagrasib cetuximab plus cemiplimab
To assess mechanisms of tumor cell adaptation upon treatment with the combination of adagrasib cetuximab plus cemiplimab
To determine mechanisms of acquired resistance to the combination of adagrasib cetuximab plus cemiplimab
To assess the effect of the combination of adagrasib cetuximab plus cemiplimab on the immune tumor microenvironment
To generate cell lines and participant derived xenograft PDX models from tumor samples
To determine the objective response rate of the adagrasib cetuximab and cemiplimab combination for treatment of advanced KRAS G12C MT CRC that has progressed on at least one line of prior systemic chemotherapy
Secondary Objectives
To estimate duration of response DOR progression free survival PFS and overall survival OS for the combination of adagrasib cetuximab and cemiplimab in participants with advanced KRAS G12C MT CRC that has progressed on at least one line of prior systemic chemotherapy
To estimate the safety and tolerability of the combination of adagrasib cetuximab and cemiplimab in participants with advanced KRAS G12C MT CRC that has progressed on at least one line of prior systemic chemotherapy
Exploratory Objectives
To assess predictive biomarkers of response and resistance to the combination of adagrasib cetuximab plus cemiplimab
To assess mechanisms of tumor cell adaptation upon treatment with the combination of adagrasib cetuximab plus cemiplimab
To determine mechanisms of acquired resistance to the combination of adagrasib cetuximab plus cemiplimab
To assess the effect of the combination of adagrasib cetuximab plus cemiplimab on the immune tumor microenvironment
To generate cell lines and participant derived xenograft PDX models from tumor samples
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04127 | OTHER | NCI-CTRP Clinical Registry | None |