Trial Summary
What is the purpose of this trial?
To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer.
Research Team
Christine Parseghian
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for patients with advanced colorectal cancer that can't be surgically removed and hasn't responded to anti-EGFR therapy. Participants should meet specific health criteria not detailed here.Inclusion Criteria
Negative serum pregnancy test required for female participants of childbearing potential within 7 days prior to enrollment
Provision of signed Informed Consent prior to any screening procedures being performed
Willing and able to participate in the trial and comply with all trial requirements
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Exclusion Criteria
Any other condition contraindicating participation in the clinical study
I haven't had cancer in the last 3 years, except for certain types.
I have had rhabdomyolysis in the past.
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Treatment Details
Interventions
- Avutometinib (RAF/MEK Inhibitor)
- Cetuximab (Monoclonal Antibody)
- Defactinib (FAK Inhibitor)
Trial OverviewThe study tests avutometinib combined with defactinib and cetuximab to see if they can manage advanced colorectal cancer that's resistant to previous treatments.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Safety Run InExperimental Treatment3 Interventions
If you are enrolled in the Safety Run In group, the dose of avutometinib you receive will depend on when you join this study. Up to 3 dose levels of avutometinib will be tested, and between 3-6 participants will be enrolled at each dose level.
The first group of participants will receive the planned starting dose level of avutometinib. Then, if no intolerable side effects are seen, a second group of participants will be enrolled to receive a higher dose. If intolerable side effects are seen, the second group will receive a lower dose. One of these 3 doses will be selected as the recommended dose of avutometinib in combination with cetuximab and defactinib.
Group II: ExpansionExperimental Treatment3 Interventions
If you are enrolled in the Expansion, you will receive avutometinib at the recommended dose that was found in Safety Run In.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Trials
3,107
Recruited
1,813,000+
Dr. Peter WT Pisters
M.D. Anderson Cancer Center
Chief Executive Officer since 2017
MD from University of Western Ontario
Dr. Jeffrey E. Lee
M.D. Anderson Cancer Center
Chief Medical Officer
MD from Stanford University School of Medicine