Actively Recruiting
Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy
Led by M.D. Anderson Cancer Center · Updated on 2026-03-12
27
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
B
BioMed Valley Discoveries, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before screening procedures.
- Age 18 years or older.
- Confirmed diagnosis of unresectable or metastatic adenocarcinoma of the colon or rectum measurable by RECIST 1.1.
- Mutation status confirmed: Cohort A must be KRAS, NRAS, EGFR ectodomain, BRAF V600E wild-type; BRAF cohort must have BRAF V600E mutation.
- Prior treatment with at least one systemic chemotherapy regimen for metastatic colorectal cancer or disease recurrence within 6 months after adjuvant chemotherapy.
- Prior anti-EGFR therapy for at least 16 weeks with complete or partial response before progression (Cohort A); prior BRAF therapy and anti-EGFR therapy for BRAF cohort.
- ECOG performance status 0 or 1.
- Recovery from acute chemotherapy effects (Grade ≤1), except alopecia or Grade 2 neuropathy; at least 21 days washout since last chemotherapy dose.
- Recovery from acute radiotherapy effects; at least 7 days washout since last radiotherapy.
- Adequate blood counts: ANC ≥1.5 x 10⁹/L; Hemoglobin ≥9 g/dL; Platelets ≥100 x 10⁹/L.
- Adequate liver function: ALT and AST ≤3x upper limit of normal (ULN), or ≤5x ULN if liver metastases; total bilirubin ≤1.5x ULN (with exceptions for indirect bilirubin and non-hepatic causes).
- Adequate kidney function: serum creatinine ≤1.5x ULN or creatinine clearance ≥50 mL/min.
- QTc interval ≤480 ms.
- Ability to take oral medications.
- Women of childbearing potential must be postmenopausal, surgically sterile, or using effective contraception; negative pregnancy test within 7 days before enrollment.
- Willingness and ability to comply with study requirements.
- Patients with prior or concurrent malignancies that do not interfere with study assessments may be included after investigator consultation.
You will not qualify if you...
- History of severe (Grade 3 or 4) allergic reactions to cetuximab, panitumumab, encorafenib, or similar compounds.
- History of red meat allergy or tick bite related allergy.
- Prior exposure to ERK1/2 inhibitors.
- Symptomatic brain metastases or leptomeningeal disease; stable asymptomatic brain metastases allowed.
- History or risk of retinal vein occlusion or central serous retinopathy.
- Previous or concurrent malignancy within 3 years except certain noninvasive or indolent cancers.
- Significant cardiovascular disease including recent acute coronary syndromes, symptomatic heart failure, serious arrhythmias, or history of sudden cardiac arrest.
- Uncontrolled high blood pressure despite treatment.
- Active systemic bacterial or fungal infection requiring IV antibiotics or antifungals at treatment start.
- HIV positive patients ineligible unless stable on HAART with specific criteria met.
- Active hepatitis B or C infection.
- Gastrointestinal conditions affecting drug absorption.
- Any condition that contraindicates participation due to safety or compliance concerns.
- Major surgery within 6 weeks before study drug start or unresolved surgical side effects.
- Pregnancy or nursing.
- Medical, psychiatric, or cognitive conditions that impair understanding or compliance with the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Christine Parseghian, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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