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Clinical Trials in the USA / NCT07361562
Recruiting Phase 1

A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors

NCT07361562 · tracked via the Priya Life Science USA tracker
Sponsor
Cogent Biosciences, Inc.
Phase
Phase 1
Started
2025-12-30
Last updated
2026-09-04

Condition(s) studied

Advanced Solid Tumor, AdultERBB2 Altered Breast CancerERBB2 Gene AmplificationHER2 OverexpressionNon-Small Cell Lung CancerHER2

Investigational drug(s) / intervention(s)

CGT4255

CGT4255: CGT4255 Daily Oral Administration

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
HonorHealth Research Institute Scottsdale Arizona Recruiting
Mayo Scottsdale Scottsdale Arizona Recruiting
Yale Cancer Center New Haven Connecticut Recruiting
Mayo Jacksonville Jacksonville Florida Recruiting
Northwestern University Chicago Illinois Recruiting
LSU Health Sciences Center School of Medicine New Orleans Louisiana Recruiting
START Midwest Grand Rapids Michigan Recruiting
Mayo Rochester Rochester Minnesota Recruiting
Washington University School of Medicine - Siteman Cancer Center St Louis Missouri Recruiting
START NY Long Island Lake Success New York Recruiting
NYU Langone New York New York Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
NEXT Oncology Texas Austin Texas Recruiting
START Mountain Region West Valley City Utah Recruiting
NEXT Oncology Virginia Fairfax Virginia Recruiting

More Cogent Biosciences, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07361562 on ClinicalTrials.gov ↗ ← All trials in the USA