drugset / Trial / NCT06008483
A Dose Finding Study to Treat Bone Tumor(s)
Non-randomizedSequentialOpen-labelTreatment
Summary
To determine the Maximum Tolerated Dose (MTD) of CycloSam®, Samarium-153-DOTMP (Sm-153-DOTMP), a radiopharmaceutical that delivers radiation to the bone when injected, given as a tandemly administered pair of doses to subjects with one or more solid tumor(s) in the bone or metastatic solid tumors to the bone that are visible on bone scan.
Timeline
- Start
- 2022-04-05
- Primary completion
- 2024-04-05
- Completion
- 2024-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAMARIUM DOTMP | Other / unclassified | 18.5 mbq/kg | Other |
| Subject | SAMARIUM DOTMP | Other / unclassified | 37 mbq/kg | Other |
| Subject | SAMARIUM DOTMP | Other / unclassified | 74 mbq/kg | Other |
| Subject | SAMARIUM DOTMP | Other / unclassified | 111 mbq/kg | Other |