A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression
Summary
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.
Arms & interventions
- DrugCGT4255
CGT4255 Daily Oral Administration
Outcome measures
Primary
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part A]
1\. Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) and AEs leading to dose modifications and dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) or the maximum evaluated dose (MED) in participants with ERBB2-altered advanced solid tumors
Time frame: Approximately 12 months
Overall Response Rate [Part B and Part C]
Overall Response Rate (ORR), determined by confirmed CR + PR of all lesions (intracranial and extracranial), based on Investigator assessment using the whole-body RECIST v1.1 in participants with ERBB2-mutated NSCLC with Brain Metastases (BM) and in participants with ERBB2-mutated or HER2-positive breast cancer with BM ± leptomeningeal disease (LMD)
Time frame: Approximately 6 months
Secondary
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part B and C]
Time frame: Approximately 7 months
Pharmacokinetics [Part A]
Time frame: Approximately 28 days
Pharmacokinetics [Part A]
Time frame: Approximately 28 days
Pharmacokinetics [Part A]
Time frame: Approximately 28 days
Pharmacokinetics [Part A)
Time frame: Approximately 28 days
Disease Response [Part A]
Time frame: Approximately 6 months
Disease Response [Part A]
Time frame: Approximately 6 months
Disease Response [Part B and Part C]
Time frame: Approximately 6 months
Disease Response [Part B and Part C]
Time frame: Approximately 6 months
Disease Response [Part B and Part C]
Time frame: Approximately 6 months
Eligibility criteria
Study locations (6)
START Midwest
Grand Rapids, Michigan, 49546
NYU Langone
New York, New York, 10016
Tennessee Oncology
Nashville, Tennessee, 37203
NEXT Oncology Texas
Austin, Texas, 78758
START Mountain Region
West Valley City, Utah, 84119
NEXT Oncology Virginia
Fairfax, Virginia, 22031