What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, particularly those involving KRAS inhibitors like sotorasib and anti-EGFR monoclonal antibodies like panitumumab, are associated with several side effects. These can include skin toxicity (such as rash), diarrhea, hypertension, anorexia, mucositis/stomatitis, and nausea. Additionally, severe adverse events like hypomagnesemia, severe skin reactions, and infusion-related reactions can occur. The combination of these therapies with chemotherapy can also increase the incidence of these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer that target specific genetic mutations and pathways. Panitumumab, an anti-EGFR monoclonal antibody, is approved for the treatment of metastatic colorectal cancer in patients with wild-type RAS genes. Cetuximab, another anti-EGFR monoclonal antibody, is also approved for similar indications. For KRAS mutations, particularly the KRAS G12C mutation, Sotorasib has shown promise in clinical trials, although its approval status for colorectal cancer specifically may still be under investigation. These targeted therapies represent a significant advancement in the personalized treatment of colorectal cancer.

What other types of research exist?

Promising novel alternatives for colorectal cancer patients in 2024 include: <ol> <li>Trifluridine/Tipiracil (Lonsurf) - a combination of a nucleoside analog and a thymidine phosphorylase inhibitor.</li> <li></li> </ol> Regorafenib (Stivarga) - a multi-kinase inhibitor targeting angiogenic, stromal, and oncogenic receptor tyrosine kinases. 3. Bevacizumab (Avastin) - a monoclonal antibody targeting VEGF, used in combination with chemotherapy. 4. Pembrolizumab (Keytruda) - an anti-PD-1 monoclonal antibody for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors. 5. Encorafenib (Braftovi) combined with Cetuximab (Erbitux) - for patients with BRAF V600E-mutant metastatic colorectal cancer.

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Monoclonal Antibodies

Sotorasib + Panitumumab for Colorectal Cancer (CodeBreak300 Trial)

Phase 3

Waitlist Available

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 Kirsten rat sarcoma (KRAS) p.G12C mutation as determined by prospective central testing, using the analytically validated Qiagen Therascreen KRAS RGQ polymerase chain reaction Kit in CRC as an investigational device demonstrating a KRAS p.G12C mutation is present. Local testing and documentation of KRAS p.G12C mutation should have been previously performed as part of standard of care.

- Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥30 mL/min/1.73 m^2.

Must not have

- Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ.

- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two doses of sotorasib combined with panitumumab in patients with a specific type of colorectal cancer that has not responded to other treatments. Sotorasib targets a genetic mutation in the cancer cells, while panitumumab helps the immune system attack the cancer. The goal is to see if this combination can help patients live longer without their cancer getting worse.

Who is the study for?

Adults over 18 with metastatic colorectal cancer that has a specific mutation (KRAS p.G12C) can join this trial. They must have tried at least one other treatment and their cancer should be measurable by certain medical criteria. Good organ function and performance status are required, but those with severe skin, breast, or prostate conditions without current disease, brain metastases treated over 4 weeks ago without progression, or other cancers cured more than 3 years ago may also qualify.

What is being tested?

The study is testing the effectiveness of Sotorasib combined with Panitumumab against either Trifluridine/Tipiracil or Regorafenib in patients whose colorectal cancer has progressed after previous treatments. The main goal is to see which combination helps slow down the cancer's growth better.

What are the potential side effects?

Potential side effects include skin reactions from Panitumumab; liver enzyme changes from Sotorasib; fatigue and hand-foot syndrome from Regorafenib; and low blood counts leading to infections, fatigue, nausea from Trifluridine/Tipiracil.

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 kidney function, based on a specific test, is at an acceptable level.

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My blood counts and organ functions are within the required ranges for the trial.

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

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My colorectal cancer has a specific KRAS mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My bladder cancer has been treated and is not invasive.

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I had skin cancer (not melanoma) treated and currently show no signs of it.

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My breast ductal carcinoma in situ has been treated and shows no signs of disease.

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I do not have serious heart conditions like recent heart attacks or unstable heart rhythms.

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I had cervical cancer that was treated and now shows no signs of the disease.

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I have or had lung scarring or inflammation.

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I have a prostate condition but no prostate cancer.

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I have a severe stomach or intestine problem that affects my nutrition.

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I have been treated with a KRAS G12C inhibitor before.

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My cancer has spread to the lining of my brain and spinal cord.

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I had blood cancer but have been free of it for over 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Average Score of Patient Global Impression of Change (PGIC)

Average Score on Single Question on Symptom Bother GP5 from Functional Assessment of Cancer Therapy - General (FACT-G)

Change from Baseline For All Subscales and Domains of EORTC QLQ-C30

+8 more

Side effects data

From 2022 Phase 1 trial • 20 Patients • NCT04887064

14%

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Normal Hepatic Function

Moderate Hepatic Impairment

Severe Hepatic Impairment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: Sotorasib 240 mg QD + panitumumabExperimental Treatment2 Interventions

Group II: Arm A: Sotorasib 960 mg QD + panitumumabExperimental Treatment2 Interventions

Group III: Arm C : Investigator's choiceActive Control2 Interventions

Participants will be administered trifluridine and tipiracil, or regorafenib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Panitumumab

2017

Completed Phase 3

~7150

Sotorasib

2021

Completed Phase 1

~370

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Sotorasib targets the KRAS G12C mutation, inhibiting a key driver of cancer cell growth, while Panitumumab is an anti-EGFR monoclonal antibody that blocks signals promoting cell division and survival. These mechanisms are crucial for tailoring treatment to colorectal cancer patients' genetic profiles, ensuring more effective and personalized therapy.

Panitumumab: a summary of clinical development in colorectal cancer and future directions.