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Monoclonal Antibodies

Sotorasib + Panitumumab + FOLFIRI for Colorectal Cancer (CodeBreaK 301 Trial)

Phase 3
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay
Central confirmation of KRAS p.G12C mutation
Must not have
Active, untreated brain metastases
Leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

"This trial aims to see if a new treatment called sotorasib, along with panitumumab and FOLFIRI, can improve the time before the cancer progresses in patients with metast

Who is the study for?
This trial is for adults with a specific mutation (KRAS p.G12C) in metastatic colorectal cancer who haven't been treated before. They should have measurable disease, be relatively active and well (ECOG ≤ 1), and have organs that are functioning properly.
What is being tested?
The study is testing if adding Sotorasib and Panitumumab to the FOLFIRI regimen improves progression free survival compared to just FOLFIRI alone or with Bevacizumab-awwb in patients with this particular genetic form of colorectal cancer.
What are the potential side effects?
Potential side effects may include diarrhea, fatigue, skin reactions from Panitumumab; high blood pressure, bleeding from Bevacizumab-awwb; and liver issues from Sotorasib. Side effects vary based on the treatment combination received.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My colorectal cancer has a specific KRAS mutation.
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My cancer has a specific KRAS mutation.
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I can carry out all my self-care but cannot do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases that haven't been treated.
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My cancer has spread to the lining of my brain and spinal cord.
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I have had or currently have lung scarring or inflammation.
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I have been treated with a KRAS p.G12C inhibitor before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Depth of Response per RECIST v1.1
Number of Participants Experiencing Adverse Events (AEs)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Sotorasib + Panitumumab + FOLFIRIExperimental Treatment3 Interventions
Sotorasib was taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI were received every 2 weeks (Q2W) via intravenous infusion (IV).
Group II: Arm B: FOLFIRI with or Without Bevacizumab-awwbActive Control2 Interventions
Participants received FOLFIRI Q2W with or without bevacizumab-awwb.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotorasib
2021
Completed Phase 1
~370
Panitumumab
2017
Completed Phase 3
~7150

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,434 Previous Clinical Trials
1,395,386 Total Patients Enrolled
MDStudy DirectorAmgen
972 Previous Clinical Trials
939,558 Total Patients Enrolled
~300 spots leftby Sep 2027
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