NCT07023848

PET Image Exploration of 89Zr-labeled Antibody Fragments Targeting HER2 in Patients With Malignant Tumors

• Status: Enrolling By Invitation
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Affiliated Hospital of Jiangnan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The following is a detailed description of the objectives of the study: Main objectives: * Application of novel radionuclide-labeled HER2-targeting molecular probes (89Zr-LNCab103 and 89Zr-LNCab104) in the early diagnosis of breast cancer, gastric cancer, urothelial carcinoma and other diseases; * To evaluate the efficacy, safety and dosimetry of 89Zr-LNCab103 and 89Zr-LNCab104 in clinical PET imaging applications. Secondary Objectives: * To investigate the biodistribution of 89Zr-LNCab103 and 89Zr-LNCab104 in patients with breast cancer, gastric cancer and urothelial carcinoma, including the distribution of primary and metastatic tumors and normal tissues, through the evaluation of whole-body imaging and SUV values using PET/CT imaging. * Compared with 18F-FDG, the clinical application value and diagnostic advantages of the novel radionuclide-labeled HER2-targeting molecular probes 89Zr-LNCab103 and 89Zr-LNCab104 were evaluated.

Conditions

• Breast Cancer
• Gastric Cancer (GC)
• Urothelial Carcinoma (UC)

Interventions

Type	Name	Description
DRUG	89Zr-LNCab104	89Zr-LNCab104 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi
DRUG	89Zr-LNCab103	89Zr-LNCab103 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi
DRUG	18F-FDG	18F-FDG is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15mCi/kg.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-07
• Completion: 2026-12-01
• First posted: 2025-06-17
• Last updated: 2025-06-17

Locations

1 site across 1 country: China