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]
Recruiting

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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.

The primary objective is to determine the maximum tolerated or evaluated doses of CGT4255 to be carried forward to Parts B and C through assessment of adverse events.

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.
Breast Cancers
Non-Small Cell Lung Cancer
Solid Tumor
Metastatic 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.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Dose Escalation
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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
Breast Cancers
Non-Small Cell Lung Cancer
Solid Tumor
Metastatic Cancer
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
Jose Pacheco
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Non-Small Cell Lung Cancer
Solid Tumor
Metastatic Cancer
Location
START New York (Long Island)
Lake Success, NY, United States, 11042
Investigator
Geraldine O'Sullivan Coyne
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Non-Small Cell Lung Cancer
Solid Tumor
Metastatic Cancer