Actively Recruiting
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
Led by Cogent Biosciences, Inc. · Updated on 2026-02-27
100
Participants Needed
6
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of advanced, metastatic, or unresectable solid tumor with documented ERBB2 alterations, NRG1 gene fusion, or HER2 overexpression (varies by study part)
- Measurable disease according to RECIST v1.1 criteria
- ECOG Performance Status 0 to 1 for Part A and 0 to 2 for Parts B and C
- Clinically acceptable local laboratory test results within specified limits
You will not qualify if you...
- Recent small molecule chemotherapy, anticancer therapies, or radiotherapy within specified timeframes before first study drug dose
- Major surgeries such as craniotomy or thoracotomy within 4 weeks before first study drug dose
- Palliative focal radiotherapy within 2 weeks or whole-brain radiotherapy within 4 weeks before first study drug dose
- Clinically significant heart disease
- Ongoing toxicities from prior therapies greater than Grade 1 (or baseline) before first dose
- Restrictions on corticosteroid use for neurologic symptoms management in study parts
AI-Screening
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Trial Site Locations
Total: 6 locations
1
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
2
NYU Langone
New York, New York, United States, 10016
Actively Recruiting
3
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
NEXT Oncology Texas
Austin, Texas, United States, 78758
Actively Recruiting
5
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
6
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
C
Cogent Biosciences, Inc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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