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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests CGT4255 in adults with advanced solid tumors that have certain gene changes or high levels of the HER2 protein. It looks at safety, how the body handles the drug, how the drug affects the body, and whether it fights cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be an adult with cancer confirmed by a tissue test.
  • Part A: A solid tumor that has grown nearby, spread, or cannot be removed by surgery. It must have an ERBB2 gene change that turns it on, an NRG1 gene fusion (joined genes), or high HER2 protein levels.
  • Part B: Non-small cell lung cancer that has grown nearby, spread, or cannot be removed by surgery. It must have an ERBB2 gene change.
  • Part C: Breast cancer that has grown nearby, spread, or cannot be removed by surgery. It must have an ERBB2 gene change or high HER protein levels.
  • Your cancer must be measurable using the study’s rules.
  • Part A: You must be fully active or limited only in hard physical tasks. Parts B and C also allow people who can care for themselves but cannot work and are up more than half the day.
  • Your blood counts and other blood test results must be within the study’s allowed limits.

Who can't join

  • You had certain cancer drugs or radiation too close to your first study dose. The waiting time depends on the treatment.
  • You had major surgery within 4 weeks before your first study dose.
  • You had focused radiation to ease symptoms within 2 weeks, or whole-brain radiation within 4 weeks, before your first study dose.
  • You have serious heart disease.
  • Side effects from past treatment, including important abnormal lab results, have not improved to mild levels or your usual level before your first study dose.
  • You use steroid medicines for brain or nerve symptoms in ways not allowed by your part of the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (15)

AZ

CT

FL

IL

LA

MI

MN

MO

NY

TN

TX

UT

VA