🏛️ Verified NIH Record • Updated 2026-06-25

CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC (NCT05774899)

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)

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Glenn J. Hanna

🩺 Plain-English Summary (8th-Grade Level)

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))

Who can join: Review the eligibility criteria below.

Location: Dana Farber Cancer Institute — Boston, Massachusetts

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (1 Sites)

  • Dana Farber Cancer Institute — Boston, Massachusetts

📞 Contact the Study Coordinator

Phone: (617) 632-3090

Email: Gjhanna@partners.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
  • 💵 Compensation indicated: 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 1...

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗