HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011
Recruiting
Phase 2
Interventional Study
Metastatic Breast Cancer
Metastatic Solid Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 60 (estimated)
- Sponsor
- Abscint NV/SA · Industry
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About This Trial
This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PET/CT in determining the HER2 expression status, and to evaluate 68Ga-ABS011's ability to drive changes in therapeutic treatment. 68Ga-ABS011 will be compared to the current standard of care (SOCa) diagnostic methods including immunohistochemistry (IHC), in situ hybridization (ISH) and imaging tools used fo…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adult (≥ 18 years at the time of informed consent signature) male or female patient
2. Patient with confirmed de novo or pre-treated metastatic solid tumors (multiple previous treatment lines in metastatic setting are allowed).
2.1. Patients with documented hormone recept…
Contacts