[68Ga]Ga-ABY-025 PET for Quantification of HER2-status in Solid Tumors

PHASE2RecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

November 23, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Esophageal NeoplasmsGastric Neoplasms MalignantBreast CancerHER2-positive Gastric Cancer
Interventions
DIAGNOSTIC_TEST

[68Ga]Ga-ABY-025 PET

\[68Ga\]Ga-ABY-025 PET: Each patient in Cohort 1 will be imaged with a PET/CT twice using the radiolabeled investigational product ABY-025 as a tracer. At the time of injection, a 45-minutes long dynamic scan will take place over a pre specified region of interest. Three hours after injection a full body PET scan followed by a CT scan will be performed.

DIAGNOSTIC_TEST

Biopsy and analysis of HER2 expression

Biopsy: Within 3 days after the first ABY-025-PET a tissue sample from at least one metastasis \>10 mm available for biopsy, preferably shallow lymph nodes, will be analyzed for HER2 expression through immunohistochemistry- (IHC) and in situ hybridization- (ISH) analysis in patients with GEAC and HER2low mBC.

Trial Locations (1)

14186

RECRUITING

Department of Radiation Physics and Nuclear Medicine, Karolinska University Hospital, Stockholm

All Listed Sponsors
lead

Karolinska University Hospital

OTHER