A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
This is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult participants with advanced solid tumors with ERBB2 alterations or HER2 overexpression.
Conditions studied
Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression, Non-Small Cell Lung Cancer, HER2
About this study
This is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult participants with advanced solid tumors with ERBB2 alterations or HER2 overexpression.
Interventions
- Drug: CGT4255 — CGT4255 Daily Oral Administration
Primary outcomes
- Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part A] (Approximately 12 months)
- Overall Response Rate [Part B and Part C] (Approximately 6 months)
Eligibility information
Study locations
- HonorHealth Research Institute, Scottsdale, Arizona 85258 United States
- Mayo Scottsdale, Scottsdale, Arizona 85281 United States
- Yale Cancer Center, New Haven, Connecticut 06510 United States
- Mayo Jacksonville, Jacksonville, Florida 32209 United States
- Northwestern University, Chicago, Illinois 60611 United States
- LSU Health Sciences Center School of Medicine, New Orleans, Louisiana 70803 United States
- START Midwest, Grand Rapids, Michigan 49546 United States
- Mayo Rochester, Rochester, Minnesota 55905 United States
- Washington University School of Medicine - Siteman Cancer Center, St Louis, Missouri 63110 United States
- START NY Long Island, Lake Success, New York 11042 United States
Showing 10 of 15 reported sites. See the official listing for all locations.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-03.