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.

NCT Number	NCT07361562
Lead Sponsor	Cogent Biosciences, Inc.
Conditions	Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression, Non-Small Cell Lung Cancer, HER2
Enrollment	100 participants
Start Date	2025-12-30
Primary Completion	2028-05 (estimated)
Study Completion	2028-11 (estimated)
Updated on ClinicalTrials.gov	2026-02-27