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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression, Non-Small Cell Lung Cancer, HER2

In brief

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.

Key facts

Study ID

NCT07361562

Run by

Cogent Biosciences, Inc.

People needed

100

Starts

2025-12-30

Expected to finish

2028-11-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have histologically confirmed diagnosis of:
• 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
• Part B: Locally advanced, metastatic, and/or unresectable NSCLC with documented ERBB2 mutation in blood and/or tumor
• Part C: Locally advanced, metastatic and/or unresectable breast cancer with documented ERBB2 mutation in blood and/or tumor or HER overexpression in tumor
• Have measurable disease per RECIST v1.1.
• 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.
• Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.

You may not qualify if…

• Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
• Major surgeries (eg, craniotomy and thoracotomy) within 4 weeks of the first dose of study drug.
• 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.
• Clinically significant cardiac disease.
• 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.
• Restrictions on use of corticosteroid use to manage neurologic symptoms in different parts of the study.

Where it is running

• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• NYU Langone — New York, New York, United States (enrolling)
• Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
• NEXT Oncology Texas — Austin, Texas, United States (enrolling)
• START Mountain Region — West Valley City, Utah, United States (enrolling)
• NEXT Oncology Virginia — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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