Pilot Study of [68Ga]Ga-ABY-025 Imaging for HER2-Targeted Therapy
This study is looking at a special imaging agent called [68Ga]Ga-ABY-025 to see if it can help doctors better see tumors in people with certain cancers. You might be able to join if you have locally advanced or metastatic cancer (cancer that has spread) and are about to start or are already receiving HER2-targeted therapy. This includes HER2-positive breast cancer, HER2-positive gastric cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and HER2-low breast cancer. The main goal is to check if [68Ga]Ga-ABY-025 is safe when used for PET scans. This study is currently unclear on its recruitment status and plans to enroll 30 people.
- Study design
- This is an interventional study with a planned enrollment of 30 participants. It is not specified if it's randomized or blinded.
- What's involved
- You will receive an injection of [68Ga]Ga-ABY-025 and have a PET/CT scan a few hours later. There will be a follow-up visit 2-7 days after the injection.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be assessed for up to 21 ± 14 days from the second administration of [68Ga]Ga-ABY-025.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Determine safety of [68Ga]Ga-ABY-025 PET by assessing for adverse events following the injection and PET imaging.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.
Outcome Measure: After study enrollment, subjects will receive \[68Ga\]Ga-ABY-025 infusion and undergo PET/CT scan. Patients will be immediately assessed for adverse events within the first 30 minutes of infusion and 2-7 days post-infusion from the study coordinator. Adverse events will be monitored up to 21±14 days following the infusion of study drug. Repeat infusion and imaging will be obtained either at the time of treatment discontinuation or at 12 months from study consent and will have the same safety monitoring parameters. While there are expected adverse events related to anti-cancer therapy, we will specifically be reporting adverse events that are "definitely related" or "probably related" to the study agent.