Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05774899

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

Led by Glenn J. Hanna · Updated on 2025-06-17

32

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

G

Glenn J. Hanna

Lead Sponsor

A

Adenoid Cystic Carcinoma Research Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed adenoid cystic carcinoma (ACC) with recurrent, metastatic, or advanced incurable disease
  • Activating mutation in the NOTCH signaling pathway
  • Prior VEGFR TKI or systemic therapy allowed only for Cohort 1
  • No prior VEGFR TKI therapy allowed for Cohort 2, but prior systemic chemotherapy allowed
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Able and willing to swallow oral capsules or tablets
  • At least one measurable lesion by RECIST v1.1
  • Adequate organ and marrow function within 14 days prior to registration
  • Proteinuria limits and testing for Cohort 2 as specified
  • Treated brain or CNS metastases allowed if stable
  • Negative pregnancy test for females of childbearing potential within 7 days before treatment
  • Use of adequate contraception for females and males of childbearing potential during and 90 days post-treatment
  • Prior or concurrent malignancy allowed if it does not interfere with study assessments
  • Recovery from prior chemotherapy acute effects with at least 21-day washout (if no radiotherapy)
Not Eligible

You will not qualify if you...

  • Untreated or symptomatic CNS metastases or carcinomatous meningitis
  • Major surgery within 14 days before study registration
  • Serious or uncontrolled preexisting medical conditions that would prevent participation
  • Gastrointestinal diseases affecting drug absorption
  • Active systemic bacterial, fungal, or detectable viral infections
  • History of significant cardiac arrhythmias or sudden cardiac arrest
  • Pregnant or breastfeeding women
  • Incomplete recovery from radiotherapy with less than 14-day washout
  • Use of anticoagulants requiring INR monitoring
  • Participation in other experimental treatments or incompatible medical research within 30 days
  • Corrected QTcF above specified limits for males and females at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

G

Glenn Hanna, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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