OncoMatch/Clinical Trials/NCT05985954
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
Is NCT05985954 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cetuximab and Ulixertinib for metastatic colorectal cancer.
Treatment: Cetuximab · Ulixertinib · Encorafenib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF v600e mutation
Required: BRAF v600e wild-type
Required: EGFR ectodomain wild-type
Required: KRAS wild-type
Required: NRAS wild-type
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic chemotherapy — metastatic or adjuvant (if recurrence/progression within 6 months)
Prior treatment with at least one systemic chemotherapy regimen for mCRC, or recurrence/progression with development of unresectable or metastatic disease within 6 months of adjuvant chemotherapy for resected colorectal cancer
Must have received: anti-EGFR therapy (cetuximab, panitumumab) — Cohort A: at least 16 weeks with CR or PR as best response, prior to progression
Cohort A: anti-EGFR therapy (cetuximab or panitumumab) setting for at least 16 weeks with either CR or PR as best response, prior to progression
Must have received: BRAF inhibitor — BRAF expansion Cohort
BRAF expansion Cohort: BRAF therapy (not including regorafenib) and anti-EGFR therapy (cetuximab or panitumumab)
Must have received: anti-EGFR therapy (cetuximab, panitumumab) — BRAF expansion Cohort
BRAF expansion Cohort: BRAF therapy (not including regorafenib) and anti-EGFR therapy (cetuximab or panitumumab)
Cannot have received: ERK1/2 inhibitor
Previously exposed to ERK1/2 inhibitor
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; Hemoglobin ≥ 9 g/dL with or without transfusions; Platelets ≥ 100 x 10^9/L without transfusions
Kidney function
serum creatinine ≤ 1.5 x ULN, or calculated creatinine clearance ≥ 50mL/min
Liver function
ALT and AST ≤3 × ULN, or ≤5 × ULN in the presence of liver metastases; total bilirubin ≤ 1.5 × ULN (exceptions for indirect bilirubin or non-hepatic causes allowed)
Cardiac function
QTc interval ≤ 480 ms (preferably the mean from triplicate ECGs)
Adequate hematologic status: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; Hemoglobin (Hgb) ≥ 9 g/dL with or without transfusions; Platelets (PLT) ≥ 100 x 10^9/L without transfusions. Adequate liver function: ALT and AST ≤3 × ULN, or ≤5 × ULN in the presence of liver metastases; total bilirubin ≤ 1.5 × ULN. Adequate renal function: either serum creatinine ≤ 1.5 x ULN, or calculated creatinine clearance ≥ 50mL/min. QTc interval ≤ 480 ms (preferably the mean from triplicate ECGs)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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