About this trial
To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed Informed Consent prior to any screening procedures being performed.
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Defactinib
DrugGiven by PO
Cetuximab
DrugGiven by IV
Avutometinib
DrugGiven by PO
Treatment groups
Trial outcomes
Primary outcomes
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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