RecruitingPhase 2NCT06369831

HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011

Evaluating the Diagnostic Performance of Human Epidermal Growth Factor Receptor 2 (HER2) Targeted Positron Emission Tomography and Computed Tomography (PET/CT) With 68Ga-ABS011 in Metastatic Breast Cancer (mBC) and Other Metastatic Solid Carcinomas.

Sponsor

Abscint NV/SA

Enrollment

60 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer Metastatic Solid Cancer

Summary

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 for treatment response follow-up including Fluorodeoxyglucose F-18 (18F-FDG) positron emitted tomography (PET) and contrast enhanced computed tomography (ceCT).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new imaging tracer that targets HER2, a protein found on some cancer cells. The goal is to improve how doctors identify which patients with metastatic breast cancer have HER2-positive tumors — even when standard tests may have missed it — to guide better treatment decisions. **You may be eligible if...** - You are 18 or older with metastatic breast cancer (cancer that has spread) - Your cancer is hormone receptor-positive/HER2-negative, triple-negative, or HER2-positive - You have at least one tumor that can be biopsied and is visible on PET/CT scan - You are willing to undergo a tumor biopsy **You may NOT be eligible if...** - You only have liver metastases visible on imaging - You are unable to undergo the required scans or biopsy procedures - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST68Ga-NOTA-ABSCINT-HER2 PET/CT

68Ga-ABS011, is a single domain antibody (sdAb) with the capability to bind HER2 tumor antigens very fast, while the unbound fraction is rapidly cleared from the blood. ABS011 is labeled with gallium-68, a short-lived isotope (68Ga, t1/2: 68 min). Combining rapid targeting of HER2, fast clearance and low radiation burden make 68Ga-ABS011 is suited for specific tumor marker whole body PET/CT imaging.