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

NCT05774899 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-06-17

No results posted yet for this study

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))

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Adenoid Cystic Carcinoma Research Foundation

    collaborator OTHER

  • Cellestia Biotech AG

    collaborator INDUSTRY

  • Glenn J. Hanna

    lead OTHER

Principal Investigators

  • Glenn Hanna, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2026-06-01
Completion
2027-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05774899 on ClinicalTrials.gov