RecruitingPhase 1Phase 2NCT05774899

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)


Sponsor

Michael J. Dennis, MD

Enrollment

32 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Abemaciclib, a drug called CB-103, and others for people with adenoid cystic carcinoma, metastatic adenoid cystic carcinoma, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCB-103

First-in-class pan-NOTCH inhibitor, capsule taken orally.

DRUGAbemaciclib

CDK4/6 inhibitor, tablet taken orally.

DRUGLenvatinib

Per standard care, capsule taken orally.


Locations(1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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NCT05774899


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