drugset / Trial / NCT06147037
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \[225Ac\]-FPI-2068, \[111In\]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC, GC, RCC).
Timeline
- Start
- 2024-07-31
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FPI-2053 | Monoclonal antibody | — | — |
| Subject | [111In]-FPI-2107 | Diagnostic / imaging agent | — | — |
| Subject | [225Ac]-FPI-2068 | Other / unclassified | — | Intravenous |