A Study of CGT4255 for Advanced Solid Tumors with ERBB2 Alterations
This study is testing a new drug called CGT4255 in adults with advanced solid tumors, including breast cancer and non-small cell lung cancer, that have specific changes in the ERBB2 gene or HER2 protein. CGT4255 is given daily by mouth. Researchers want to understand how safe CGT4255 is and what side effects it might cause. They also want to see how well the drug works against the cancer. To join, your tumor must have an ERBB2 alteration or HER2 overexpression. The study aims to enroll 100 participants. The current status of this study is unclear.
- Study design
- This is an open-label, phase 1/1b study, meaning both you and the study team will know you are receiving CGT4255. It plans to enroll 100 adult participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure side effects for about 12 months and how well the drug works for about 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
At a glance
Conditions
Where it's being run
6 sites across 6 statesWho to contact
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What this trial measures
- Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part A]Approximately 12 months
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
- Overall Response Rate [Part B and Part C]Approximately 6 months
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)