drugset / Trial / NCT06184035
A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this first-in-human (FIH) study is to determine the maximum tolerated dose (MTD) and to characterize the safety, tolerability, PK, and dosimetry profile of \[177Lu\]Lu-SN201 in adult participants with advanced solid tumors who have no standard of care treatment options. \[177Lu\]Lu-SN201 is a radiolabeled, nanomedical investigational medicinal product (IMP) whose mechanism of delivery is based on the Enhanced Permeability and Retention (EPR) effect.
Timeline
- Start
- 2023-12-06
- Primary completion
- 2027-12-01
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | [177Lu]Lu-SN201 | Unknown | 10 mbq/kg | Intravenous |
| Subject | [177Lu]Lu-SN201 | Unknown | 25 mbq/kg | Intravenous |
| Subject | [177Lu]Lu-SN201 | Unknown | 50 mbq/kg | Intravenous |