What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as Cetuximab (an EGFR inhibitor) and KRAS G12C inhibitors like MRTX849, are associated with several side effects. Cetuximab frequently causes skin toxicity, including rash, gastrointestinal issues, infusion-related reactions, and febrile neutropenia. KRAS G12C inhibitors typically present side effects such as gastrointestinal disturbances, fatigue, and potential liver enzyme elevations. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer, particularly those targeting the EGFR pathway. Cetuximab, an EGFR inhibitor, is approved for use in patients with KRAS wild-type metastatic colorectal cancer. Another EGFR inhibitor, panitumumab, is also approved for similar indications. While specific KRAS G12C inhibitors like MRTX849 are still under investigation, the approval of these EGFR inhibitors highlights the importance of targeted therapies in the treatment of colorectal cancer.

What other types of research exist?

Promising novel alternatives for colorectal cancer treatment in 2024 include: 1) Panitumumab, another anti-EGFR antibody, especially for patients with wild-type KRAS. 2) Bevacizumab, an anti-VEGF antibody, often used in combination with chemotherapy. 3) Immunotherapy agents like Pembrolizumab and Atezolizumab, particularly for patients with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). 4) Targeted therapies such as Encorafenib combined with Cetuximab for BRAF V600E-mutant colorectal cancer. These alternatives offer different mechanisms of action and can be tailored based on the patient's specific genetic profile.

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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.

Must not have

Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).

Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new treatment for patients with colorectal cancer. The treatment combines two drugs that work together to block cancer growth and prevent its spread. One of the drugs has shown promise in treating other types of cancer as well.

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.

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.

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

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My colorectal cancer has a specific KRAS G12C mutation.

Select...

My advanced colorectal cancer progressed after first-line chemotherapy.

Exclusion Criteria

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

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I have been treated with an anti-EGFR antibody before.

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I have been treated with a drug targeting the KRAS G12C mutation.

Select...

I have active cancer spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Progression-free Survival (PFS)

Secondary study objectives

Adverse Events

Duration of Response (DOR)

Objective Response Rate (ORR)

+2 more

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: MRTX849 + CetuximabExperimental Treatment2 Interventions

Group II: mFOLFOX6 or FOLFIRIActive Control2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

0 / 5Eligibility 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

Colorectal cancer treatments often target specific molecular pathways involved in tumor growth and survival. MRTX849 is a KRAS G12C inhibitor that works by specifically targeting and inhibiting the mutant KRAS G12C protein, which is involved in cell proliferation and survival. This inhibition can lead to reduced tumor growth in patients with this specific mutation. Cetuximab, an EGFR inhibitor, works by binding to the epidermal growth factor receptor (EGFR) on the surface of cancer cells, blocking the signaling pathways that promote cell division and survival. This is particularly effective in tumors without RAS mutations. These targeted therapies are crucial as they offer more personalized and effective treatment options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

The molecular therapy of colorectal cancer.