Trials / Active Not Recruiting
Active Not RecruitingNCT05722327
Phase I Trial of Adagrasib (MRTX849) in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 and/or blood plasma. * To explore correlations between baseline tumor biomarkers, gene alterations, and clinical activity/efficacy. * 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MRTX849 | Given by PO (mouth) |
| DRUG | Irinotecan | Given by IV (vein) |
| DRUG | Cetuximab | Given by IV (vein) |
Timeline
- Start date
- 2023-12-06
- Primary completion
- 2027-09-30
- Completion
- 2027-09-30
- First posted
- 2023-02-10
- Last updated
- 2026-03-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05722327. Inclusion in this directory is not an endorsement.