Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
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.
Breast,
Phase I
Phase I
Adults
Not Available
Not Available
Rosenthal, Eben
Local
Vanderbilt University
04-22-2026
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
1. Age 18 years.
2. 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.
3. 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.
4. Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver.
5. Life expectancy of at least 6 months. Patients with brain metastases are permitted to enroll in this study.
Exclusion Criteria:
1. Measurable sites of disease only in the liver.
2. Inability to comply with study procedures.
3. Hypersensitivity or allergy to any component of \[68Ga\]Ga-ABY-025.
4. Pregnant or breastfeeding.
5. HER2-negative cancers that have no FDA approved indication for treatment with HER2-directed therapy.
6. Inability to lie flat for 30 minutes during an imaging session.
7. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.
1. Age 18 years.
2. 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.
3. 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.
4. Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver.
5. Life expectancy of at least 6 months. Patients with brain metastases are permitted to enroll in this study.
Exclusion Criteria:
1. Measurable sites of disease only in the liver.
2. Inability to comply with study procedures.
3. Hypersensitivity or allergy to any component of \[68Ga\]Ga-ABY-025.
4. Pregnant or breastfeeding.
5. HER2-negative cancers that have no FDA approved indication for treatment with HER2-directed therapy.
6. Inability to lie flat for 30 minutes during an imaging session.
7. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.
