Advanced Solid Tumor, Adult study: CGT4255
Official title A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07361562
What this study is testing
What is CGT4255?
CGT4255 is an investigational oral medicine being studied as a potential treatment for advanced solid tumors with ERBB2 alterations or HER2 overexpression.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn how safe the drug is, how the body handles it, and whether it shows any anti‑cancer activity.
- Who it's for
- Adults with advanced solid tumors that have ERBB2 (HER2) alterations or HER2 over‑expression.
- What's involved
- Participants will receive the study drug and have regular check‑ups, blood draws, and imaging scans to monitor safety and tumor response.
- Time commitment
- The trial runs for several months with multiple clinic visits for treatment and assessments.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part A: Locally advanced, metastatic, and/or unresectable solid tumor with documented ERBB2-activating alteration or NRG1 gene fusion in blood and/or...
- Part B: Locally advanced, metastatic, and/or unresectable NSCLC with documented ERBB2 mutation in blood and/or tumor
- Part C: Locally advanced, metastatic and/or unresectable breast cancer with documented ERBB2 mutation in blood and/or tumor or HER overexpression in...
- Have measurable disease per RECIST v1.1.
- 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.
You likely can't join if
- Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
- Major surgeries (eg, craniotomy and thoracotomy) within 4 weeks of the first dose of study drug.
- Treatment with palliative focal radiotherapy (cranial or extracranial) (eg, stereotactic radiosurgery or intensity-modulated radiation therapy) ≤2...
- Clinically significant cardiac disease.
- Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities...
- Restrictions on use of corticosteroid use to manage neurologic symptoms in different parts of the study.
See the full eligibility criteria
- 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
- Part B: Locally advanced, metastatic, and/or unresectable NSCLC with documented ERBB2 mutation in blood and/or tumor
- Part C: Locally advanced, metastatic and/or unresectable breast cancer with documented ERBB2 mutation in blood and/or tumor or HER overexpression in tumor
- Have measurable disease per RECIST v1.1.
- 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.
- Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.
- Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
- Major surgeries (eg, craniotomy and thoracotomy) within 4 weeks of the first dose of study drug.
- 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
- Clinically significant cardiac disease.
- 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.
- Restrictions on use of corticosteroid use to manage neurologic symptoms in different parts of the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Lake Success, New York, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; New Orleans, Louisiana, United States; Grand Rapids, Michigan, United States and 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.