Status: Recruiting
A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer
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.
Participants needed: 90
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Spago Nanomedical ABUpdated: Nov 20, 2025Locations: 2
Eligibility criteria
Male or female participants ≥ 18 years of age on the day of signing informed con... [+19]
Unstable systemic disease (including but not limited to active infection, hepati... [+20]