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KRAS G12C Inhibitor

Adagrasib + Cetuximab + Cemiplimab for Colorectal Cancer

Phase 1 & 2

Recruiting

Led By Christine Parseghian, 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

Unresectable or metastatic disease

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Major surgery within 4 weeks of the first dose of any study drug

Prior PD1 or CTLA4 inhibition therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test if a combination of three drugs can effectively treat metastatic colorectal cancer in patients with a specific genetic mutation."

Who is the study for?

This trial is for adults with advanced colorectal cancer that has spread, specifically those with a KRAS G12C mutation. Participants must have had at least one prior chemotherapy treatment and be able to take oral medication. They should not have serious illnesses or conditions that could affect the study's results or their ability to participate, including certain infections or autoimmune diseases.

What is being tested?

The trial is testing a combination of three drugs: Adagrasib, Cetuximab, and Cemiplimab in patients with metastatic colorectal cancer harboring KRAS G12C mutations. The goal is to see if this drug combo can control the disease better than current treatments.

What are the potential side effects?

Potential side effects may include skin reactions from cetuximab; immune-related issues like inflammation of organs from cemiplimab; and gastrointestinal symptoms, fatigue, liver enzyme changes from adagrasib. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer cannot be removed by surgery or has spread.

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I am fully active or have some restrictions but can still care for myself.

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My colorectal cancer is advanced, not responsive to certain DNA repairs, and has a specific genetic change.

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My cancer has a KRASG12C mutation.

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I've had chemotherapy for my cancer that has spread, but it didn't work or I couldn't tolerate it.

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I am 18 years old or older.

Exclusion Criteria

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

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I have not had major surgery in the last 4 weeks.

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I have previously received PD1 or CTLA4 inhibitor therapy.

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I have previously received treatment targeting the KRASG12C mutation.

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I have symptoms from cancer spread to the lining of my brain and spinal cord.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Lead-InExperimental Treatment3 Interventions

Participants enrolled in the Lead-In phase, the dose of adagrasib participants receive will depend on when the participant join this study. The first group of participants will receive the starting dose level of adagrasib. If intolerable side effects are seen, a second group of participants will be enrolled to receive a lower dose. One (1) of these 2 doses will be chosen as the recommended dose of adagrasib.

Group II: ExpansionExperimental Treatment3 Interventions

Participants enrolled in the Expansion phase, participants will receive adagrasib at the recommended dose that was found in the Lead-In phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1470

Cetuximab

2011