Phase 1 Study of 177Lu-IM-3050 for Treating Advanced Solid Tumors Expressing FAP

What this Trial Is About

Researchers are evaluating 177Lu-IM-3050, a FAP-directed radiopharmaceutical, in participants with advanced solid tumors that express fibroblast activation protein FAP. This Phase 1 study aims to determine the safety, tolerability, dosimetry, pharmacokinetics, and early anti-tumor activity of 177Lu-IM-3050 in people with advanced cancer who have relapsed or are refractory to previous treatments. The study includes two parts dose escalation and dose expansion, to establish the recommended dose for further development. In Part A, participants receive escalating repeated doses of 177Lu-IM-3050 administered intravenously every 6 weeks to assess safety, tolerability, and preliminary anti-tumor effects while determining the maximum tolerated dose or recommended expansion dose. Part B involves treating participants with the recommended dose to further evaluate safety and tolerability. Each treatment cycle lasts 6 weeks, and dosimetry assessments occur up to 8 days after Cycle 3 or until discontinuation. Participants will be monitored for treatment-emergent adverse events from the first dose through at least 42 days after the last dose, with safety follow-up lasting up to approximately five years. Evaluations include blood and plasma radioactivity levels, tumor response assessments starting at Week 6, and FAP PETCT imaging tracer safety. The total participation duration may extend up to several years to monitor long-term effects and outcomes.

A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer