drugset / Trial / NCT06416774
A Clinical Study of 68Ga-HX01 Injection for PET Imaging
Phase 1
Completed
22 enrolled
Hexin (Suzhou) Pharmaceutical Technology Co., Ltd
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · collab
Non-randomizedParallel-groupOpen-labelDiagnostic
Summary
This is a single-center, open Phase I clinical study, consisting of two parts: a Phase Ia study in healthy adult subjects and a Phase Ib study in patients with malignant solid tumors.
Timeline
- Start
- 2022-12-29
- Primary completion
- 2023-07-20
- Completion
- 2023-10-30
Publications
- Zhang X, Gai Y, Ye T, Fan L, Xiu L, Ruan W, Hu F, Chen J, Lan X. Head-to-head evaluation of [18F]FDG PET/CT and [68Ga]Ga-HX01 PET/MR in sarcoma patients. Eur J Nucl Med Mol Imaging. 2025 Jul;52(8):2898-2905. doi: 10.1007/s00259-025-07130-4. Epub 2025 Feb 20.
- Zhang X, Fang H, Yang B, Qin C, Hu F, Ruan W, Chen J, Zeng D, Gai Y, Lan X. Phase I study of [68Ga]Ga-HX01 for targeting integrin alphavbeta3 and CD13 in healthy and malignancy subjects. Eur J Nucl Med Mol Imaging. 2025 Mar;52(4):1293-1304. doi: 10.1007/s00259-024-07002-3. Epub 2024 Nov 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 68Ga-HX01 | Diagnostic / imaging agent | 0.05 unknown | Intravenous |
| Subject | 68Ga-HX01 | Diagnostic / imaging agent | 0.07 unknown | Intravenous |
| Subject | 68Ga-HX01 | Diagnostic / imaging agent | 0.1 unknown | Intravenous |