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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

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

Qualifiers

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.

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

Treatments tested in this trial

  • Defactinib
  • Cetuximab
  • Avutometinib

Treatment groups

33 Participants
are divided into 2 treatment groups

Sponsors and collaborators