Approval Probability
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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 being studied for the treatment of advanced solid tumors in adults, including ERBB2 altered breast cancer, HER2 overexpressing tumors, and non-small cell lung cancer with HER2 alterations. It is currently in Phase 1 clinical development and has not been approved by the FDA.
CGT4255 targets ErbB2, also known as HER2, a receptor tyrosine kinase. By inhibiting ERBB2, the drug is designed to interfere with signaling pathways that drive tumor growth in cancers with ERBB2 alterations, such as gene amplification or overexpression.
CGT4255 is being developed by Cogent Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol COGT. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced solid tumors.
CGT4255 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being studied in clinical trials to assess its safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.
CGT4255 is being evaluated in a Phase 1 clinical trial with the identifier NCT07361562. This open-label, controlled study is recruiting approximately 100 adult patients with advanced solid tumors, including ERBB2 altered breast cancer and non-small cell lung cancer, at sites in the United States.
CGT4255 is a selective ERBB2 inhibitor and is not known by any alternative names. It is a distinct investigational compound being developed by Cogent Biosciences for the treatment of advanced solid tumors with HER2 alterations.