Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722327
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-02-01
Brief Title:
Phase I Trial of Adagrasib MRTX849 in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Trial of Adagrasib MRTX849 in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
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 find the recommended dose of MRTX849 that can be given in combination with cetuximab and irinotecan to patients with colorectal cancer that have a mutation genetic change called KRAS G12C
Detailed Description:
Primary objectives
To determine the optimal biological dose OBD of MRTX849 when used in combination with cetuximab and irinotecan
To evaluate the safety profile of this combination
To determine the antitumor activity of this combination in patients with metastatic KRASG12C colorectal cancer
Exploratory objectives
To explore correlations between MRTX849 exposure and patient outcomes such as disease response objective response rate ORR duration or response DOR progression-free survival PFS overall survival OS safety and pharmacodynamic endpoints
To evaluate the utility of detecting KRASG12C mutation in plasma to identify suitable patients
To explore potential pharmacodynamic PD markers of KRASG12C and EGFR inhibition in tumor tissue andor blood plasma
To explore correlations between baseline tumor biomarkers gene alterations and clinical activityefficacy
To define mechanisms of acquired resistance to EGFR and KRASG12C inhibition and evaluate novel strategies to overcome such resistance
To assess pharmacokinetics of MRTX849 and irinotecan and key metabolites
To determine the optimal biological dose OBD of MRTX849 when used in combination with cetuximab and irinotecan
To evaluate the safety profile of this combination
To determine the antitumor activity of this combination in patients with metastatic KRASG12C colorectal cancer
Exploratory objectives
To explore correlations between MRTX849 exposure and patient outcomes such as disease response objective response rate ORR duration or response DOR progression-free survival PFS overall survival OS safety and pharmacodynamic endpoints
To evaluate the utility of detecting KRASG12C mutation in plasma to identify suitable patients
To explore potential pharmacodynamic PD markers of KRASG12C and EGFR inhibition in tumor tissue andor blood plasma
To explore correlations between baseline tumor biomarkers gene alterations and clinical activityefficacy
To define mechanisms of acquired resistance to EGFR and KRASG12C inhibition and evaluate novel strategies to overcome such resistance
To assess pharmacokinetics of MRTX849 and irinotecan and key metabolites
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-2023-01157 | OTHER | NCI-CTRP Clinical Trials Registry | None |