Menu
Recruiting NCT07361562

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

Phase I Interventional Advanced Solid Tumor, Adult ERBB2 Altered Breast Cancer ERBB2 Gene Amplification HER2 Overexpression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CGT4255.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug CGT4255
    CGT4255 Daily Oral Administration

Primary outcome measures

  • Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part A] [Time frame: Approximately 12 months]
  • Overall Response Rate [Part B and Part C] [Time frame: Approximately 6 months]
Secondary outcome measures (10)
  • Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part B and C] [Time frame: Approximately 7 months]
  • Pharmacokinetics [Part A] [Time frame: Approximately 28 days]
  • Pharmacokinetics [Part A] [Time frame: Approximately 28 days]
  • Pharmacokinetics [Part A] [Time frame: Approximately 28 days]
  • Pharmacokinetics [Part A) [Time frame: Approximately 28 days]
  • Disease Response [Part A] [Time frame: Approximately 6 months]
  • Disease Response [Part A] [Time frame: Approximately 6 months]
  • Disease Response [Part B and Part C] [Time frame: Approximately 6 months]
  • Disease Response [Part B and Part C] [Time frame: Approximately 6 months]
  • Disease Response [Part B and Part C] [Time frame: Approximately 6 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • START Midwest — Grand Rapids
  • NYU Langone — New York
  • Tennessee Oncology — Nashville
  • NEXT Oncology Texas — Austin
  • START Mountain Region — West Valley City
  • NEXT Oncology Virginia — Fairfax

Identifiers

NCT: NCT07361562 · CGT4255-25-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗