Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-04-01
33
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before screening
- Age 18 years or older at consent
- Confirmed adenocarcinoma of colon or rectum with unresectable or metastatic disease measurable by RECIST 1.1
- Tumor or circulating DNA shows wild-type KRAS, NRAS, EGFR ectodomain, and BRAF V600E at diagnosis
- Prior systemic chemotherapy for metastatic colorectal cancer or progression within 6 months of adjuvant chemotherapy
- Prior anti-EGFR therapy (cetuximab or panitumumab) for at least 16 weeks with complete or partial response before progression
- ECOG performance status 0 or 1
- Recovery from acute chemotherapy effects except alopecia or grade 2 peripheral neuropathy; at least 21-day washout from chemotherapy
- Recovery from radiotherapy side effects; at least 7-day washout from radiotherapy
- Adequate blood counts: ANC ≥ 1.5 x 10^9/L, Hemoglobin ≥ 9 g/dL, Platelets ≥ 100 x 10^9/L
- Adequate liver function: ALT and AST ≤ 3 x ULN or ≤ 5 x ULN if liver metastases; bilirubin ≤ 1.5 x ULN and < 1.5 mg/dL
- Adequate kidney function: Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 40 mL/min
- QTc interval ≤ 480 ms
- Ability to take oral medications
- If sexually active female of childbearing potential, negative pregnancy test and effective contraception
- Willingness and ability to participate and comply with trial requirements
- Prior or concurrent malignancies allowed if not interfering with safety or efficacy
You will not qualify if you...
- History of severe allergic reaction or intolerance to cetuximab or panitumumab
- Allergies to compounds similar to cetuximab or history of red meat allergy/tick bite
- Prior treatment with ERK1/2, MEK, or BRAF inhibitors
- Symptomatic brain metastases
- Known leptomeningeal disease
- History or risk of retinal vein occlusion or central serous retinopathy
- Other malignancies within 3 years except certain treated skin, bladder, prostate, cervical, or indolent cancers
- Significant cardiovascular diseases including recent acute coronary syndromes, symptomatic heart failure, serious arrhythmias, uncontrolled hypertension
- Active systemic bacterial or fungal infection requiring IV treatment
- Active HIV infection requiring therapy
- Active hepatitis B or C infection as defined
- Impaired gastrointestinal function affecting drug absorption
- Any other condition judged unsafe or interfering with study participation
- Major surgery within 6 weeks or incomplete recovery from surgery side effects
- Systemic anti-cancer therapy within 4 weeks or within 5 half-lives of prior drug
- Pregnant or nursing women
- History of rhabdomyolysis
- Medical, psychiatric, or cognitive conditions compromising consent or protocol compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77807
Actively Recruiting
Research Team
C
Christine Parseghian, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here