CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC
Trial Parameters
Brief Summary
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))
Eligibility Criteria
Participants must meet the following eligibility criteria at the time of screening to be eligible to participate in the study: Eligibility Criteria 1. Participants must have histologically confirmed adenoid cystic carcinoma (ACC) with evidence of recurrent, metastatic or advanced, incurable disease arising from any primary site 2. Activating mutation in the NOTCH signaling pathway 3. In Cohort 1 only, prior multitargeted VEGFR TKI or systemic therapy is permitted. 4. In Cohort 2 only, no prior multitargeted VEGFR TKI therapy is permitted, but prior systemic chemotherapy as part of definitive or curative intent management is permitted. a. Any participant must obtain prior approval from insurance to reimburse for oral Lenvatinib, or off-label drug assistance to secure Lenvatinib for the duration of the study or agree to self-pay for oral Lenvatinib or obtain institutional commitment from the study site to provide Lenvatinib. 5. Age 18 years or older 6. Eastern Cooperative Oncology Group