Trials / Completed
CompletedNCT07299253
Preclinical Safety Evaluation and First-in-Human Translational Study of [177Lu]Lu-TEFAPI-06
Preclinical Safety Evaluation and First-in-Human Translational Study of [177Lu]Lu-TEFAPI-06: A Novel Albumin-Binding FAPI Radiopharmaceutical for Theranostics
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Lanzhou University Second Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to systematically evaluate the safety, biodistribution, dosimetry, and preliminary therapeutic potential of \[177Lu\]Lu-TEFAPI-06 through an exploratory first-in-human (FIH) trial.
Detailed description
This study represents a comprehensive "bench-to-bedside" translational investigation, providing the first systematic report on the safety profile of \[177Lu\]Lu-TEFAPI-06-a novel albumin-binding fibroblast activation protein inhibitor (FAPI) radiopharmaceutical-and its successful transition into a FIH. The investigators preliminarily evaluated its safety, dosimetry, and therapeutic response in patients with ibroblast activation protein (FAP)-overexpressing metastatic solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | radionuclide therapy with [177Lu]Lu--TEFAPI-06 | A Novel Albumin-Binding FAPI Radiopharmaceutical for Theranostics |
Timeline
- Start date
- 2023-08-16
- Primary completion
- 2024-08-16
- Completion
- 2025-08-16
- First posted
- 2025-12-23
- Last updated
- 2025-12-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07299253. Inclusion in this directory is not an endorsement.