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

This trial does not accept healthy volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Defactinib

    Drug

    Given by PO

  • Cetuximab

    Drug

    Given by IV

  • Avutometinib

    Drug

    Given by PO

Treatment groups

33 Participants
are divided into 2 treatment groups
Group A: Safety Run InExperimental treatment 3 interventions
Group B: ExpansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.