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Ulixertinib and Cetuximab for Metastatic Colorectal Cancer

This study is testing different combinations of drugs for people with metastatic colorectal cancer (cancer that has spread). It is looking at ulixertinib, cetuximab, and encorafenib. These drugs target specific pathways in cancer cells, like RAF and EGFR. You may be able to join if you have previously received treatment that targeted EGFR or BRAF. The main goal is to find the safest and most effective dose of ulixertinib when given with cetuximab, with or without encorafenib. Researchers will also look at how safe and effective these drug combinations are, including how long people respond to treatment and how long they live. This study plans to enroll 27 participants, but its current recruitment status is unclear.

Study design
This is an open-label study, meaning both you and the study team will know which drugs you are receiving. It is designed to find the right dose of the study drugs and will include 27 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects through study completion, which is 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.

NCT05985954

Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~27 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:CetuximabUlixertinibEncorafenib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured over through study completion; an average of 1 year

Conditions

Metastatic 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) 792-2828
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) \<12 months prior to screening,
Symptomatic chronic heart failure (i.e. NYHA class 3 or higher), history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality \<6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia,
The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. 7. Uncontrolled hypertension defined as persistent elevation of systolic blood pressure ≥ 170 mmHg or diastolic blood pressure ≥ 100 mm Hg, despite current therapy; 8. The patient has active systemic bacterial or fungal infection (requiring intravenous (IV) antibiotics and/or antifungals at time of initiating study treatment). 9. Participants positive for HIV are ineligible unless they meet all of the following:
HBsAg(+), HBV DNA ≤200 IU/mL and persistent or intermittent elevation of ALT/AST and/or liver biopsy showing chronic hepatitis with moderate or severe necroinflammation.
Note: Participants who are HBsAg(-), HBcAb(+) are eligible and should be monitored/treated as per local standard of care.
HCV antibody positive; AND
Presence of HCV RNA. 11. Impaired gastrointestinal function or disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption). 12. Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. 13. Major surgery ≤ 6 weeks prior to starting study drug or failure to recover from side effects of such procedure at the discretion of the treating investigator. 14. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 15. Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study

What this trial measures

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0through study completion; an average of 1 year