drugset / Trial / NCT06298916
64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
Non-randomizedSequentialOpen-labelDiagnostic
Summary
This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to compare its imaging biodistribution with FAP expression by IHC in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2).
Timeline
- Start
- 2025-08
- Primary completion
- 2025-11
- Completion
- 2026-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 64Cu-LNTH-1363S | Diagnostic / imaging agent | 90 ug | — |
| Subject | 64Cu-LNTH-1363S | Diagnostic / imaging agent | 296 mbq | — |