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

Study Identifier:
CGT4255-25-101
CT.gov Identifier:
NCT07361562
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Breast
  • Biomarkers
  • Non-Small Cell Lung Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Dose Escalation
    • Read More
  • Drug: Part A: Dose Escalation Multiple doses of CGT4255 for oral administration
  • Drug: Drug: CGT4255
  • Drug: CGT4255 Daily Oral Administration
  • Drug: EXPERIMENTAL: Signal Seeking and Dose Escalation
  • Drug: Part B: Signal Seeking and Dose Optimization Oral dose(s) of CGT4255 at the selected dose levels determined in Phase 1
  • Drug: EXPERIMENTAL: Signal Seeking
  • Drug: Part C: Includes signal seeking. Participants will receive CGT4255 at a dose level selected based on data from Part A
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion 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.
    Exclusion 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Breast
    Biomarkers
    Non-Small Cell Lung Cancer
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    Jose Pacheco
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Breast
    Biomarkers
    Non-Small Cell Lung Cancer
    Location
    START New York (Long Island)
    Lake Success, NY, United States, 11042
    Investigator
    Geraldine O'Sullivan Coyne
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Breast
    Biomarkers
    Non-Small Cell Lung Cancer