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New treatment option for Locally Advanced Cancer
Official title Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
ClinicalTrials.gov ID: NCT06828588
What this study is testing
What is [68Ga]Ga-ABY-025?
[68Ga]Ga-ABY-025 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for locally advanced cancer.
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 purpose of this study is to determine if the radiotracer, [68Ga]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.
- 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
- Age ≥ 18 years.
- Patients with unresectable locally advanced or metastatic cancer who are eligible for standard of care treatment with HER2-targeted therapy per the...
- Must have a previous biopsy demonstrating HER2 expression in at least one lesion (HER2+ solid cancer, or breast cancer patients who are HER2+ or...
- Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver.
- Life expectancy of at least 6 months. Patients with brain metastases are permitted to enroll in this study.
You likely can't join if
- Measurable sites of disease only in the liver.
- Inability to comply with study procedures.
- Hypersensitivity or allergy to any component of [68Ga]Ga-ABY-025.
- Pregnant or breastfeeding.
- HER2-negative cancers that have no FDA approved indication for treatment with HER2-directed therapy.
- Inability to lie flat for 30 minutes during an imaging session.
See the full eligibility criteria
- Age ≥ 18 years.
- Patients with unresectable locally advanced or metastatic cancer who are eligible for standard of care treatment with HER2-targeted therapy per the discretion of their treating physician for an FDA-approved indication...
- Must have a previous biopsy demonstrating HER2 expression in at least one lesion (HER2+ solid cancer, or breast cancer patients who are HER2+ or HER2-low) as defined by IHC and FISH studies or with HER2 amplification as...
- Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver.
- Life expectancy of at least 6 months. Patients with brain metastases are permitted to enroll in this study.
- Measurable sites of disease only in the liver.
- Inability to comply with study procedures.
- Hypersensitivity or allergy to any component of [68Ga]Ga-ABY-025.
- Pregnant or breastfeeding.
- HER2-negative cancers that have no FDA approved indication for treatment with HER2-directed therapy.
- Inability to lie flat for 30 minutes during an imaging session.
- Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, 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 - 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?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.