A Phase I/IIa, Dose Escalation and Dose Expansion, First-in-human, Open-label, Multicenter, Single-arm Study Evaluating the Safety, Tolerability, Dosimetry, and Early Efficacy of [177Lu]Lu-SN201 in Participants With Progressive or Treatment-refractory Locally Advanced Unresectable, Metastatic or Recurrent Solid Tumors

Description:

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.