Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [68Ga]Ga-ABY-025.
- Who it may be relevant to
- Registry conditions: Locally Advanced Cancer, Metastatic Cancer, HER2, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This study will assess a dose of ABY-025 followed by a tracer dose of \[68Ga\]Ga-ABY-025 in subjects with HER2+ solid cancers, or HER2+ or low breast cancer undergoing or planning to undergo treatment with standard-of-care HER2-targeted therapy for an FDA-approved indication. The study drug will be administered and \[68Ga\]Ga-ABY-025 PET/CT scan will be obtained the same day after injection of study drug. Patients will have a follow visit 2-7 days post injection of the study drug. Additionally, subjects will undergo standard of care evaluation of their advanced disease per the discretion of their treating physician.
Interventions
- Drug [68Ga]Ga-ABY-025
Subjects receive a tracer dose of \[68Ga\]Ga-ABY-025 and will receive a PET/CT scan a few hours after the injection.
Primary outcome measures
- Determine safety of [68Ga]Ga-ABY-025 PET by assessing for adverse events following the injection and PET imaging. [Time frame: up to 21± 14 days from second administration of [68Ga]Ga-ABY-025. Assessments will be performed as part of the routine standard of care for patients undergoing HER2-targeted anti-cancer treatment.]
Eligibility criteria
Inclusion 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. Patients who are planning to start HER2-targeted therapy at the time of study enrollment. Patients who have recently begun HER2 treatment and have received no more than 6 cycles will be eligible for enrollment.
- 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 defined by a liquid biopsy that was done as standard of care testing for the patient's cancer type.
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT06828588 · VICCBREP24601