OncoMatch/Clinical Trials/NCT07361562
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
Is NCT07361562 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies CGT4255 for advanced solid tumor, adult.
Treatment: CGT4255 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Breast Carcinoma
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) activating alteration
Part A: ...solid tumor with documented ERBB2-activating alteration
Required: NRG1 fusion
Part A: ...solid tumor with documented...NRG1 gene fusion in blood and/or tumor
Required: HER2 (ERBB2) overexpression
Part A: ...solid tumor with...HER2 overexpression in tumor
Required: HER2 (ERBB2) mutation
Part B: ...NSCLC with documented ERBB2 mutation in blood and/or tumor
Required: HER2 (ERBB2) mutation
Part C: ...breast cancer with documented ERBB2 mutation in blood and/or tumor
Required: HER2 (ERBB2) overexpression
Part C: ...breast cancer with...HER overexpression in tumor
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: small molecule chemotherapy or anticancer therapies or radiotherapy
Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug
Lab requirements
Blood counts
clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
Kidney function
clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
Liver function
clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- START Midwest · Grand Rapids, Michigan
- NYU Langone · New York, New York
- Tennessee Oncology · Nashville, Tennessee
- NEXT Oncology Texas · Austin, Texas
- START Mountain Region · West Valley City, Utah
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07361562 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior small molecule chemotherapy or anticancer therapies or radiotherapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 activating alteration is a required biomarker for enrollment.
Does this trial require NRG1?
Yes, NRG1 fusion is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify