PET imaging with [68Ga]Ga-ABY-025 to visualize HER2-positive and HER2-low tumors during HER2 therapy
Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
This trial will test whether a PET tracer called [68Ga]Ga-ABY-025 can better visualize tumors in adults with HER2-positive or HER2-low advanced cancers who are receiving HER2-targeted therapy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06828588 on ClinicalTrials.gov |
What this trial studies
Participants who have HER2-positive solid cancers or HER2-positive or HER2-low breast cancer and are starting or receiving FDA-approved HER2-targeted therapy will receive a dose of ABY-025 followed by a tracer dose of [68Ga]Ga-ABY-025. A PET/CT scan will be performed the same day after tracer injection to image tumor HER2 expression, and participants will have a safety follow-up visit 2–7 days later. Eligible patients must have prior biopsy or validated liquid biopsy evidence of HER2 expression or amplification and measurable disease outside the liver. Standard-of-care disease evaluations by the treating physician will continue alongside the investigational imaging.
Who should consider this trial
Good fit: Adults with unresectable locally advanced or metastatic HER2-positive or HER2-low tumors who have prior biopsy or validated liquid biopsy showing HER2 expression or amplification, measurable disease outside the liver, and who are planning to start or are within the first six cycles of FDA-approved HER2-targeted therapy.
Not a fit: Patients without documented HER2 expression, those with only liver-only measurable disease, patients not receiving HER2-targeted therapy, or those with a life expectancy under six months are unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, this imaging could help doctors detect and map HER2-expressing lesions more precisely and guide treatment decisions.
How similar studies have performed: Early clinical work with 68Ga-ABY-025 and related HER2-targeted affibody PET tracers has shown promising lesion detection and correlation with HER2 status in small cohorts, but larger validation remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Makenna Brown
- Email: makenna.l.brown@vumc.org
- Phone: +1 (615)421-4370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.