The Exploration of Novel Radionuclide-labeled HER2-targeting Antibodies in the Diagnosis of HER2-positive Malignancies
NCT07023861 · Status: ENROLLING_BY_INVITATION · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-06-17
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.
Conditions
- Breast Cancer
- Gastric Cancer (GC)
- Urothelial Carcinoma (UC)
Interventions
- DRUG
-
18F-FDG
18F-FDG is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15 mCi/kg.
- DRUG
-
89Zr-LNCab190
89Zr-LNCab190 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi
- DRUG
-
89Zr-LNCab002
89Zr-LNCab002 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi
- DRUG
-
89Zr-LNCab072
89Zr-LNCab072 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi
Sponsors & Collaborators
-
Affiliated Hospital of Jiangnan University
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 15 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-01
- Primary Completion
- 2026-07-07
- Completion
- 2026-12-01
Countries
- China
Study Locations
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