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Monoclonal Antibodies

MRTX849 + Cetuximab for Colorectal Cancer

Phase 3
Waitlist Available
Research Sponsored by Mirati Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights

Study Summary

This trial is testing a new drug, MRTX849, to see if it is better than chemotherapy at treating colorectal cancer that has a KRAS G12C mutation.

Who is the study for?
This trial is for adults with advanced colorectal cancer who have the KRAS G12C mutation. They must have had one prior treatment with specific chemotherapy and shown disease progression afterwards. People can't join if they've had brain metastases, previous treatments targeting KRAS G12C, or anti-EGFR antibody therapies.Check my eligibility
What is being tested?
The study compares MRTX849 combined with cetuximab to standard chemotherapies (mFOLFOX6 or FOLFIRI) in second-line treatment of colorectal cancer with a specific mutation. It's an open-label trial where patients are randomly assigned to either the new drug combo or standard chemo.See study design
What are the potential side effects?
Potential side effects may include skin reactions from cetuximab, typical chemotherapy-related issues like nausea, fatigue, low blood counts leading to increased infection risk, and possible liver enzyme changes due to MRTX849.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My colorectal cancer has a specific KRAS G12C mutation.
Select...
My advanced colorectal cancer progressed after first-line chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Progression-free Survival (PFS)
Secondary outcome measures
Adverse Events
Duration of Response (DOR)
Objective Response Rate (ORR)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MRTX849 + CetuximabExperimental Treatment2 Interventions
Group II: mFOLFOX6 or FOLFIRIActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRTX849
2021
Completed Phase 1
~10
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
7,794 Total Patients Enrolled
Andrew Chi, MD, Ph.DStudy DirectorMirati Therapeutics
Hirak Der-Torossian, MDStudy DirectorMirati Therapeutics
3 Previous Clinical Trials
738 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04793958 — Phase 3
Colorectal Cancer Research Study Groups: mFOLFOX6 or FOLFIRI, MRTX849 + Cetuximab
Colorectal Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT04793958 — Phase 3
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04793958 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators still enrolling individuals for this research project?

"That is correct, the information available on clinicaltrials.gov demonstrates that this trial is currently opened to recruitment. The study was first posted on March 15th, 2021 and has been updated as recently as November 3rd, 2022. A total of 420 patients will be recruited from 100 different sites."

Answered by AI

In how many different medical clinics is this clinical trial being run today?

"There are 100 enrolling patients for this trial at locations such as Memorial Sloan Kettering Cancer Center - New york in New York, SCRI Tennessee Oncology Nashville Centennial in Nashville, and Research Site in Jacksonville."

Answered by AI

What are the goals of this research?

"The primary goals of this long-term study are to track the Overall Survival rate of patients. Additionally, researchers hope to gain insights into Objective Response Rate, Patient Reported Outcomes, and Duration of Response."

Answered by AI

Which conditions does MRTX849 commonly address?

"MRTX849 is an effective treatment against rectal carcinoma, colorectal carcinoma, and ovarian cancer."

Answered by AI

How many individuals have signed up to participate in this research project?

"That is accurate. The latest information on clinicaltrials.gov indicates that this study is currently seeking patients. This particular trial was initially posted on March 15th, 2021 and updated November 3rd, 2022. In total, 420 patients are needed across 100 sites."

Answered by AI

What is the official government stance on MRTX849?

"MRTX849 safety is estimated to be a 3. This is based on the fact that it is a Phase 3 trial, meaning efficacy has been supported by some data and safety has been backed up by multiple rounds of research."

Answered by AI

What are the most recent findings concerning MRTX849?

"There are currently 634 different clinical trials studying MRTX849 with 167 of them in Phase 3. Most of these experiments are conducted in Pittsburgh, although there are 29376 total locations where trials for MRTX849 take place."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Alabama
How old are they?
65+
What site did they apply to?
Research Site
Winship Cancer Institute
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Phone Call
Most responsive sites:
  1. Inova Schar Cancer Institute: < 24 hours
Recent research and studies
clinicaltrials.govStudy
Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
2021. "Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04793958.
All > Colorectal Cancer Glendale
~98 spots leftby Feb 2025
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