Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CGT4255 · 1 trial · 6 indications
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 (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)
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Part A: Dose Escalation Multiple doses of CGT4255 for oral administration |
| Signal Seeking and Dose Escalation | EXPERIMENTAL | Part B: Signal Seeking and Dose Optimization Oral dose(s) of CGT4255 at the selected dose levels determined in Phase 1 |
| Signal Seeking | EXPERIMENTAL | Part C: Includes signal seeking. Participants will receive CGT4255 at a dose level selected based on data from Part A |
| Name | Type | Description |
|---|---|---|
| CGT4255 | DRUG | CGT4255 Daily Oral Administration |
Inclusion Criteria: 1. Have histologically confirmed diagnosis of: 1. Part A: Locally advanced, metastatic, and/or unresectable solid tumor with documented ERBB2-activating alteration or NRG1 gene fusion in blood and/or tumor or HER2 overexpression in tumor 2. Part B: Locally advanced, metas...
CGT4255 is an investigational small molecule developed by Cogent Biosciences, Inc. for the treatment of advanced solid tumors in adults. It is designed as a selective ERBB2 inhibitor and is currently in Phase 1 clinical development. It has not been approved by the FDA and remains an investigational agent.
CGT4255 is being studied for advanced solid tumors in adults, including ERBB2 altered breast cancer, ERBB2 gene amplification, HER2 overexpression, and non-small cell lung cancer with HER2 alterations. It is an investigational therapy and is not approved for any indication.
CGT4255 targets ErbB2, also known as HER2, a receptor in the ErbB family of receptor tyrosine kinases. It is described as a selective ERBB2 inhibitor, meaning it is designed to act on ErbB2 specifically. The Phase 1 trial enrolls patients whose tumors have ERBB2 alterations.
CGT4255 is being developed by Cogent Biosciences, Inc., which trades on the Nasdaq under the ticker COGT. The company is running the Phase 1 study of the compound in the United States.
CGT4255 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA. The single Phase 1 trial is currently recruiting participants, and no trials of the drug have been completed.
CGT4255 is being evaluated in one Phase 1 trial, NCT07361562, titled A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors. The trial is recruiting in the United States, plans to enroll about 100 adults aged 18 and older, and includes biomarker-selected patients with ERBB2 alterations.