OncoMatch/Clinical Trials/NCT05774899
CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC
Is NCT05774899 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including CB-103 and Abemaciclib for adenoid cystic carcinoma.
Treatment: CB-103 · Abemaciclib · Lenvatinib — The goal of this study is to treat patients with NOTCH active advanced adenoid cystic carcinoma (ACC) tumors with a combination or two different oral medications to slow tumor growth and improve survival outcomes. The names of the study drugs involved in this study are: * CB-103 (an oral NOTCH pathway inhibitor) * Abemaciclib (CDK4/6 inhibitor) * Lenvatinib (a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI))
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: NOTCH activating mutation
Activating mutation in the NOTCH signaling pathway
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
ANC ≥1.5 x 10^9/L; Hemoglobin ≥9 g/dL (patients may receive erythrocyte transfusions to achieve this hemoglobin level); Platelet count ≥100 x 10^9/L (without transfusion within the last 5 days)
Kidney function
serum creatinine ≤1.5x ULN or serum creatinine clearance (CrCl) ≥50 mL/min (estimated by Cockcroft-Gault formula)
Liver function
AST and ALT ≤3x ULN; total serum bilirubin ≤1.5x ULN (patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted)
Cardiac function
Corrected QTcF >450 msec for males and >470 msec for females in screening [excluded]
Participant must have organ and marrow function as defined below within 14 days prior to study registration (ULN=upper limit of normal per institution): Absolute neutrophil count (ANC) ≥1.5 x 10^9/L Hemoglobin (Hgb) ≥9 g/dL (patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion). Platelet count ≥100 x 10^9/L (without transfusion within the last 5 days) Serum creatinine ≤1.5x ULN or serum creatinine clearance (CrCl) ≥50 mL/min (estimated by Cockcroft-Gault formula) Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3x ULN Total serum bilirubin ≤1.5x ULN (patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted). Corrected QTcF >450 msec for males and >470 msec for females in screening [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana Farber Cancer Institute · Boston, Massachusetts
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