Trials / Recruiting
RecruitingNCT07361562
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Cogent Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Advanced Solid Tumor, Adult
- ERBB2 Altered Breast Cancer
- ERBB2 Gene Amplification
- HER2 Overexpression
- Non-Small Cell Lung Cancer
- HER2
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CGT4255 | CGT4255 Daily Oral Administration |
Timeline
- Start date
- 2025-12-30
- Primary completion
- 2028-05-01
- Completion
- 2028-11-01
- First posted
- 2026-01-23
- Last updated
- 2026-02-27
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07361562. Inclusion in this directory is not an endorsement.