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New treatment option for Advanced Colorectal Cancer
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
ClinicalTrials.gov ID: NCT06369259
What this study is testing
What is Defactinib?
Defactinib is an investigational medicine, being studied as a potential treatment for advanced colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed Informed Consent prior to any screening procedures being performed.
- Non-English speaking participants will be eligible for participation with involvement of the MD Anderson Language Assistance department in the...
- Individuals lacking the ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of participation in...
- 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...
You likely can't join if
- History of grade 3 or 4 allergic reaction or intolerability attributed to cetuximab or panitumumab.
- History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab, or if the patient had red...
- Previously exposed to ERK1/2, MEK or BRAF inhibitor
- Any known symptomatic brain metastasis
- Note: Participants previously treated or untreated for this condition who are asymptomatic in the absence of corticosteroid and anti-epileptic...
- Known leptomeningeal disease
See the full eligibility criteria
- Provision of signed Informed Consent prior to any screening procedures being performed.
- 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 DNA (prior to any anti-EGFR directed therapy):
- 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...
- 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.
- Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral...
- Participants who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 7 days is required between end of radiotherapy and day 1 of study.
- Adequate hematologic status: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Hemoglobin (Hgb) ≥ 9 g/dL with or without transfusions; Platelets (PLT) ≥ 100 x 109/L without transfusions
- Adequate liver function:
- 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...
- 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...
- 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 how well it works assessment of the investigational agent may be included...
- History of grade 3 or 4 allergic reaction or intolerability attributed to cetuximab or panitumumab.
- History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab, or if the patient had red meat allergy/tick bite history.
- Previously exposed to ERK1/2, MEK or BRAF inhibitor
- Any known symptomatic brain metastasis
- Note: Participants previously treated or untreated for this condition who are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Known brain metastases must be stable for ≥ 4 weeks...
- Known leptomeningeal disease
- A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
- Previous or concurrent malignancy within 3 years of study entry, with the following exceptions: adequately treated basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm...
- Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following: 1\. History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.