The Exploration of Novel Radionuclide-labeled HER2-targeting Antibodies in the Diagnosis of HER2-positive Malignancies

Phase 0 Enrolling by invitation 20 enrolled Affiliated Hospital of Jiangnan University

Non-randomizedCrossoverOpen-labelDiagnostic

Summary

The purpose of this study is to develop and clinically evaluate 89Zr-labeled HER2-targeted antibodies in diagnosis and screening of HER2-positive cancer patients.

Timeline

Start: 2025-07-01
Primary completion: 2026-07-07
Completion: 2026-12-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	18F-FDG	Diagnostic / imaging agent	3.7 mbq/kg	Intravenous
Subject	18F-FDG	Diagnostic / imaging agent	5.55 mbq/kg	Intravenous
Subject	89Zr-LNCab002	Protein / enzyme biologic	37 mbq	Intravenous
Subject	89Zr-LNCab002	Protein / enzyme biologic	111 mbq	Intravenous
Subject	89Zr-LNCab072	Protein / enzyme biologic	37 mbq	Intravenous
Subject	89Zr-LNCab072	Protein / enzyme biologic	111 mbq	Intravenous
Subject	89Zr-LNCab190	Protein / enzyme biologic	37 mbq	Intravenous
Subject	89Zr-LNCab190	Protein / enzyme biologic	111 mbq	Intravenous

The Exploration of Novel Radionuclide-labeled HER2-targeting Antibodies in the Diagnosis of HER2-positive Malignancies

Summary

Timeline

Drugs

Indications