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OncoMatch/Clinical Trials/NCT07361562

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

Is NCT07361562 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CGT4255 for advanced solid tumor, adult.

Phase 1RecruitingCogent Biosciences, Inc.NCT07361562Data as of May 2026

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.

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Extracted eligibility criteria

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 →

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