Recruiting
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.
ClinicalTrials.gov IDNCT07361562
PhasePHASE1
Enrollment100
SponsorCogent Biosciences, Inc.
Age18 Years
SexALL
Conditions studied
Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression, Non-Small Cell Lung Cancer, HER2
About this study
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.
Interventions
- Drug: CGT4255 — CGT4255 Daily Oral Administration
Primary outcomes
- Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part A] (Approximately 12 months)
- Overall Response Rate [Part B and Part C] (Approximately 6 months)
Eligibility information
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, metastatic, and/or unresectable NSCLC with documented ERBB2 mutation in blood and/or tumor
3. Part C: Locally advanced, metastatic and/or unresectable breast cancer with documented ERBB2 mutation in blood and/or tumor or HER overexpression in tumor
2. Have measurable disease per RECIST v1.1.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 for Part A. For Parts B and C, ECOG Performance Status must be 0 to 2.
4. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.
Exclusion Criteria:
1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
2. Major surgeries (eg, craniotomy and thoracotomy) within 4 weeks of the first dose of study drug.
3. Treatment with palliative focal radiotherapy (cranial or extracranial) (eg, stereotactic radiosurgery or intensity-modulated radiation therapy) ≤2 weeks before the first dose of study drug; treatment with whole-brain radiotherapy ≤4 weeks before the first dose of study drug.
4. Clinically significant cardiac disease.
5. Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug.
6. Restrictions on use of corticosteroid use to manage neurologic symptoms in different parts of the study.
Study locations
- HonorHealth Research Institute, Scottsdale, Arizona 85258 United States
- Mayo Scottsdale, Scottsdale, Arizona 85281 United States
- Yale Cancer Center, New Haven, Connecticut 06510 United States
- Mayo Jacksonville, Jacksonville, Florida 32209 United States
- Northwestern University, Chicago, Illinois 60611 United States
- LSU Health Sciences Center School of Medicine, New Orleans, Louisiana 70803 United States
- START Midwest, Grand Rapids, Michigan 49546 United States
- Mayo Rochester, Rochester, Minnesota 55905 United States
- Washington University School of Medicine - Siteman Cancer Center, St Louis, Missouri 63110 United States
- START NY Long Island, Lake Success, New York 11042 United States
Showing 10 of 15 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.