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Monoclonal Antibodies
Adagrasib + Cetuximab + Irinotecan for Colorectal Cancer
Phase 1
Recruiting
Led By David S. Hong, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial tests a potential cancer drug combo to treat colorectal cancer with a KRAS mutation.
Who is the study for?
Adults with colorectal cancer that has spread and have a specific genetic change called KRAS G12C. They must have tried at least two chemotherapy treatments, be in good physical condition (ECOG 0 or 1), and have normal organ function tests. Women who can get pregnant and men with partners who can get pregnant must agree to use birth control during the study.Check my eligibility
What is being tested?
The trial is testing the safety of combining a new drug, Adagrasib (MRTX849), with Cetuximab and Irinotecan in patients whose colorectal cancer has this KRAS G12C mutation. The goal is to find the best dose for this combination treatment.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion, changes in blood counts, liver enzyme alterations, fatigue, digestive issues like diarrhea or constipation from Irinotecan; skin reactions from Cetuximab; plus any unknown risks from the new drug Adagrasib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Stage 2 ( MRTX849 and Irinotecan)Experimental Treatment3 Interventions
Participants assigned to Stage 2 will receive MRTX849 and irinotecan at the dose level that was recommended during Stage 1. This study will also test 2 different dosing schedules: concurrent dosing or staggered dosing
Group II: Stage 1 ( MRTX849 and Irinotecan)Experimental Treatment3 Interventions
Participants assigned to Stage 1, participants dose levels of MRTX849 and irinotecan will depend on when the participants joined the study. This study will also test 2 different dosing schedules: concurrent dosing or staggered dosing
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRTX849
2021
Completed Phase 1
~10
Irinotecan
2017
Completed Phase 4
~2680
Cetuximab
2011
Completed Phase 3
~2480
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,372 Total Patients Enrolled
Mirati TherapeuticsUNKNOWN
David S. Hong, MDPrincipal InvestigatorM.D. Anderson Cancer Center
14 Previous Clinical Trials
537 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from previous cancer treatments with minimal side effects.My brain metastases are treated and I've been stable for 2 weeks.I have been treated with a KRASG12C and EGFR inhibitor combination.I have had major stomach surgery or intestinal disease.I have heart problems.I have HIV or active Hepatitis B or C.I might have another type of cancer besides the one being studied.I agree to use birth control during the study.My colon or rectum cancer has a specific KRASG12C mutation.My cancer cannot be removed by surgery or has spread to other parts of my body.I have had two or more chemotherapy treatments for my cancer that has spread.My cancer can be measured using specific criteria.I am 18 years old or older.I can take pills by mouth.I stopped my last cancer treatment at least 2 weeks ago or before its half-life ended, whichever came first.I am fully active or restricted in physically strenuous activity but can do light work.I have not had major surgery in the last 4 weeks.I have cancer cells in the fluid around my brain and spinal cord.I haven't had serious coughing up of blood or bleeding in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1 ( MRTX849 and Irinotecan)
- Group 2: Stage 2 ( MRTX849 and Irinotecan)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent are patients at risk when undergoing Stage 1 (MRTX849 and Irinotecan) treatments?
"Our team at Power evaluated the safety of MRTX849 and Irinotecan in a Phase 1 trial, where there is limited data to support efficacy, thus receiving a score of 1."
Answered by AI
Are there remaining vacancies in this clinical trial?
"The clinicaltrials.gov page does not show evidence of this trial actively seeking patients at the moment, as its last update was in February 1st 2023. Nonetheless, 1182 other research studies are currently recruiting volunteers on that website."
Answered by AI
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