NCT06828588 Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
| NCT ID | NCT06828588 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Vanderbilt-Ingram Cancer Center |
| Condition | Locally Advanced Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-04-16 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-04-16 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06828588 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06828588 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06828588 currently recruiting?
Yes, NCT06828588 is actively recruiting participants. Contact the research team at makenna.l.brown@vumc.org for enrollment information.
Where is the NCT06828588 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT06828588 clinical trial?
NCT06828588 is sponsored by Vanderbilt-Ingram Cancer Center. The trial plans to enroll 30 participants.
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