NCT05774899

CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC

A Phase 1/2 Study of CB-103 (Oral Pan-NOTCH Inhibitor) With Abemaciclib or Lenvatinib in Combination in Patients With NOTCH Activated Adenoid Cystic Carcinoma (CALCulus)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Glenn J. Hanna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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))

Detailed description

This is a phase 2, open-label, non-randomized, parallel cohort, multicenter study investigating the novel pan-NOTCH inhibitor, CB-103, in combination with the CDK4/6 inhibitor, Abemaciclib, and CB-103 in combination with the multi-targeted vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), Lenvatinib for patients with advanced, incurable, or metastatic adenoid cystic carcinoma (ACC) with a Notch pathway activating mutation. Participants will be placed into one of two treatment groups: Cohort 1: CB-103 + Abemaciclib or Cohort 2: VEGFR TKI Lenvatinib + CB-103. The U.S. Food and Drug Administration (FDA) has not approved CB-103 as a treatment for any disease. The FDA has not approved Abemaciclib or Lenvatinib for advanced adenoid cystic carcinoma (ACC)), but it has been approved for other uses or cancer types. Study procedures include screening for eligibility, treatment visits, radiologic scans of tumors, and blood tests. Participation in this study is expected to last about 2 years or until disease progression, therapy intolerance, or participant withdrawal. It is expected that about 32 people will take part in this research study. Cellestia Biotech AG is supporting this research study by providing funding.

Conditions

• Adenoid Cystic Carcinoma
• Metastatic Adenoid Cystic Carcinoma
• Recurrent Adenoid Cystic Carcinoma

Interventions

Type	Name	Description
DRUG	CB-103	First-in-class pan-NOTCH inhibitor, capsule taken orally.
DRUG	Abemaciclib	CDK4/6 inhibitor, tablet taken orally.
DRUG	Lenvatinib	Per standard care, capsule taken orally.

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2023-03-20
• Last updated: 2025-06-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study