RecruitingRecruiting
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
NCT07361562 · Cogent Biosciences, Inc.
In plain English
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Official title
A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression
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.
Eligibility criteria
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 design
Enrollment target: 100 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-30
Estimated completion: 2028-11
Last updated: 2026-02-27
Interventions
Drug: CGT4255
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)
Sponsor
Cogent Biosciences, Inc. · industry
Contacts & investigators
ContactCogent Biosciences, Inc · contact · trialinfo@cogentbio.com · 617-945-5576
All locations (6)
START MidwestRecruiting
Grand Rapids, Michigan, United States
NYU LangoneRecruiting
New York, New York, United States
Tennessee OncologyRecruiting
Nashville, Tennessee, United States
NEXT Oncology TexasRecruiting
Austin, Texas, United States
START Mountain RegionRecruiting
West Valley City, Utah, United States
NEXT Oncology VirginiaRecruiting
Fairfax, Virginia, United States