Actively Recruiting
A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression
Led by Cogent Biosciences, Inc. · Updated on 2026-02-27
100
Participants Needed
6
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CGT4255, a selective ERBB2 inhibitor, in adults with advanced solid tumors that have ERBB2 genetic alterations or HER2 overexpression. This open-label, phase 1/1b study aims to assess the safety, tolerability, how the body processes the drug, how the drug affects the body, and its antitumor activity in these patients. The study is sponsored by Cogent Biosciences, Inc.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Histologically confirmed diagnosis of locally advanced, metastatic, or unresectable solid tumors with ERBB2-activating alterations, NRG1 gene fusion, or HER2 overexpression for Part A
- Diagnosis of locally advanced, metastatic, or unresectable non-small cell lung cancer with ERBB2 mutation for Part B
- Diagnosis of locally advanced, metastatic, or unresectable breast cancer with ERBB2 mutation or HER2 overexpression for Part C
- Measurable disease according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 for Part A and 0 to 2 for Parts B and C
- Clinically acceptable local laboratory screening results (clinical chemistry and hematology) within set limits
You will not qualify if you...
- Received small molecule chemotherapy, anticancer therapies, or radiotherapy within specified timeframes before first dose of study drug
- Had major surgeries such as craniotomy or thoracotomy within 4 weeks before first dose
- Received palliative focal radiotherapy within 2 weeks or whole-brain radiotherapy within 4 weeks before first dose
- Clinically significant cardiac disease
- Did not resolve toxicities from prior therapy to Grade 1 or baseline before first dose
- Restrictions on corticosteroid use to manage neurologic symptoms in different study parts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months depending on trial part and participant response
Participants receive daily oral doses of CGT4255 as part of dose escalation, signal seeking, or dose optimization depending on their trial part.
Regular visits during treatment period to monitor safety and response
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
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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