RecruitingPhase 1NCT07361562

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

A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression


Sponsor

Cogent Biosciences, Inc.

Enrollment

100 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral targeted drug called CGT4255 for people with advanced solid tumors that have changes in a gene called ERBB2 (also known as HER2), which drives tumor growth. It tests the drug alone and potentially in combination with other treatments. **You may be eligible if...** - You have advanced, unresectable, or metastatic cancer with a documented ERBB2 mutation, HER2 overexpression, or NRG1 gene fusion (Part A: any solid tumor; Part B: non-small cell lung cancer; Part C: breast cancer) - Your cancer has measurable disease on scans - You are well enough to carry out daily activities (ECOG 0–1 for Part A; 0–2 for Parts B and C) - Your blood and organ function tests are within acceptable ranges **You may NOT be eligible if...** - You received chemotherapy or targeted therapy too recently before the study - You had major surgery (such as chest or brain surgery) within 4 weeks of starting the study - You have significant heart problems - You still have unresolved serious side effects from prior cancer treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCGT4255

CGT4255 Daily Oral Administration


Locations(6)

START Midwest

Grand Rapids, Michigan, United States

NYU Langone

New York, New York, United States

Tennessee Oncology

Nashville, Tennessee, United States

NEXT Oncology Texas

Austin, Texas, United States

START Mountain Region

West Valley City, Utah, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07361562