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Phase 2 Study of Avutometinib, Defactinib, and Cetuximab for Advanced Colorectal Cancer

This study is testing if a combination of three drugs – avutometinib, defactinib, and cetuximab – can help control advanced colorectal cancer that has not responded to anti-EGFR treatments. Researchers want to see how well this combination shrinks tumors and if it helps people live longer. They will also carefully watch for any side effects. You might be able to join if you are 18 or older, have advanced colorectal cancer that cannot be removed by surgery, and have not responded to anti-EGFR treatments. The study plans to enroll 33 participants.

Study design
This is an open-label Phase 2 study, meaning both you and your doctors will know which treatments you are receiving. It plans to enroll 33 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and any side effects will be monitored throughout the study, which is expected to last an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06369259

Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~33 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:DefactinibCetuximabAvutometinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year.

Conditions

Advanced Colorectal Cancer

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Christine Parseghian, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Christine Parseghian, MD
[email protected]
(713) 795-9280
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Non-English speaking participants will be eligible for participation with involvement of the MD Anderson Language Assistance department in the informed consent process (per MD Anderson SOP 04\_Informed Consent Process).
Individuals lacking the ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of participation in this study will not be eligible for participation.
Age ≥ 18 years at the time of informed consent.
Histologically (or cytologically) confirmed diagnosis of adenocarcinoma of the colon or rectum, with clinical confirmation of unresectable and/or metastatic disease that is measurable according to RECIST1.1 criteria.
Mutation status at the time of colorectal cancer diagnosis performed on tumor tissue or circulating tumor
KRAS, NRAS, EGFR ectodomain, BRAF V600E wild-type status
Prior treatment with at least one systemic chemotherapy regimen for mCRC, or recurrence/progression with development of unresectable or metastatic disease within 6 months of adjuvant chemotherapy for resected colorectal cancer.
Prior treatment with:
anti-EGFR therapy (cetuximab or panitumumab) setting for at least 16 weeks with either CR or PR as best response, prior to progression • ECOG performance status ≤ 1.
ALT and AST ≤3 × ULN, or ≤5 × ULN in the presence of liver metastases
Total bilirubin ≤ 1.5 × ULN and \< 1.5 mg/dL
Note: Participants with hyperbilirubinemia due to non-hepatic cause (e.g., hemolysis, hematoma) may be enrolled following discussion and agreement with the principal investigator. • Adequate renal function: Serum Creatinine ≤ 1.5 x ULN, or calculated creatinine clearance (measured via 24-hour urine collection) ≥ 40 mL/min at screening
QTc interval ≤ 480 ms (preferably the mean from triplicate ECGs)
Able to take oral medications.
Because the teratogenicity of cetuximab is not known, the participant, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods). Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment
Willing and able to participate in the trial and comply with all trial requirements.
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agent may be included after consultation with the medical monitor.

What this trial measures

  • Safety and adverse events (AEs)Through study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0