NCT06828588

Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Locally Advanced Cancer
• Metastatic Cancer
• HER2
• HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma
• HER 2 Low-expressing Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-12-01
• Completion: 2029-12-01
• First posted: 2025-02-14
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study