RecruitingPhase 1NCT07361562
Official study title

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

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.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCGT4255

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · HER2

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 4, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?15 U.S. locations

Locations may change over time.

Who runs it?Cogent Biosciences, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Cogent Biosciences, Inc.
Interventions being studied
Drug: CGT4255
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • HonorHealth Research InstituteScottsdale, Arizona
  • Mayo ScottsdaleScottsdale, Arizona
  • Yale Cancer CenterNew Haven, Connecticut
  • Mayo JacksonvilleJacksonville, Florida
  • Northwestern UniversityChicago, Illinois
  • LSU Health Sciences Center School of MedicineNew Orleans, Louisiana
  • START MidwestGrand Rapids, Michigan
  • Mayo RochesterRochester, Minnesota
  • Washington University School of Medicine - Siteman Cancer CenterSt Louis, Missouri
  • START NY Long IslandLake Success, New York
  • NYU LangoneNew York, New York
  • Tennessee OncologyNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 4, 2026. Always confirm current availability with the study team.

View original record ↗