drugset / Trial / NCT06184035

A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer

NCT06184035 ↗

Phase 1/2 Recruiting 90 enrolled Spago Nanomedical AB
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

EvaluationDrugModalityDoseRoute
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