Ulixertinib + Cetuximab / Encorafenib for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
To find the recommended dose of ulixertinib that can be given in combination with cetuximab and/or encorafenib to patients with unresectable/metastatic CRC and who have received EGFR or BRAF-directed therapy in the past.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, there is a required 'washout period' (time without taking certain medications) of at least 21 days after your last chemotherapy dose and 7 days after radiotherapy before starting the study.
What safety data exists for Ulixertinib + Cetuximab / Encorafenib in humans?
The combination of encorafenib and cetuximab has been studied in patients with metastatic colorectal cancer, showing common side effects like fatigue, nausea, diarrhea, skin rash, and decreased appetite. Cetuximab, when used with irinotecan, has shown skin toxicity, diarrhea, and fatigue as side effects, but severe side effects were rare.12345
What makes the drug combination of Ulixertinib, Cetuximab, and Encorafenib unique for colorectal cancer?
This drug combination is unique because it targets the BRAFV600E mutation in metastatic colorectal cancer, which is a specific genetic change in the cancer cells. Encorafenib and Cetuximab have shown improved survival rates compared to standard treatments, and the addition of Ulixertinib may enhance the effectiveness of this targeted therapy.16789
What data supports the effectiveness of the drug combination Ulixertinib + Cetuximab / Encorafenib for colorectal cancer?
Cetuximab, when used with other drugs like FOLFIRI, has been shown to improve survival and response rates in patients with certain types of metastatic colorectal cancer. This suggests that Cetuximab can be effective in treating colorectal cancer, especially when combined with other treatments.25101112
Who Is on the Research Team?
Christine Parseghian
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Adults over 18 with unresectable/metastatic colorectal cancer who've had prior EGFR or BRAF therapy can join. They must have adequate organ function, be able to take oral meds, and use effective contraception if of childbearing potential. Exclusions include previous ERK1/2 inhibitor exposure, certain infections like hepatitis B/C, heart conditions, uncontrolled hypertension, recent major surgery, pregnancy/nursing status.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ulixertinib in combination with cetuximab and/or encorafenib to determine the maximally tolerated dose and recommended phase 2 dose
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of overall response rate and duration of response
Exploratory
Correlative studies performed using blood and tissue specimens to assess biomarkers and pharmacodynamic markers
What Are the Treatments Tested in This Trial?
Interventions
- Cetuximab
- Encorafenib
- Ulixertinib
Cetuximab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
BioMed Valley Discoveries, Inc
Industry Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University