Phase IIIa Study of 177LuLu-SN201 for Safety and Early Effectiveness in Adults with Advanced or Treatment-Resistant Solid Tumors

What this Trial Is About

Researchers are evaluating the investigational drug 177LuLu-SN201 in adults with advanced solid tumors that have no standard treatment options. This first-in-human study aims to find the maximum tolerated dose and to understand the safety, tolerability, pharmacokinetics, and dosimetry of 177LuLu-SN201, a radiolabeled nanomedicine designed to target tumors through a special delivery mechanism called the Enhanced Permeability and Retention effect. Participants will receive 177LuLu-SN201 through slow intravenous infusion, starting with one treatment cycle and potentially progressing to up to three cycles if retreatment criteria are met. Each cycle occurs every six weeks, with a possible delay of up to three weeks. The study involves dose escalation across up to five dose levels to identify the best tolerated dose, followed by an expansion phase to further assess safety and early effectiveness in various tumor types. The first treatment cycle requires an overnight hospital stay for observation. Throughout the study, participants will undergo imaging scans such as whole-body planar imaging, SPECTCT, CT, or MRI to monitor how the drug distributes in the body and to assess tumor response. Researchers will regularly check for side effects and monitor laboratory tests for organ function. Participants may receive up to three treatment cycles over about 22 weeks, with safety and disease control rates tracked for up to 48 months. Ongoing assessments will include adverse events, drug levels in blood, and clinical benefits in different tumor groups.

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