A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer
Start Date
6/19/2026
Completion Date
12/1/2034
Summary
IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.
Detailed Description
IM-3050-101 is a 2-part Phase 1 first-in-human (FIH), open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, dosimetry, pharmacokinetics (PK), and preliminary anti-tumor activity of the radiopharmaceutical 177Lu-IM-3050 in participants with FAP-expressing advanced solid tumors. Part A of the study is a dose escalation phase to evaluate the safety, tolerability, preliminary anti-tumor activity, radiation dosimetry, and PK from escalating repeated doses of 177Lu-IM-3050 to determine maximum tolerated dose (MTD) and/or recommended expansion dose of 177Lu-IM-3050. Part B of the study is an expansion phase to further evaluate safety and tolerability of 177Lu-IM-3050 at the candidate recommended dose.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
177Lu-IM-3050
Conditions
Locations
XCancer Research Network / Dothan Hematology & Oncology
Dothan, Alabama 36303
United States
Stanford University School of Medicine
Palo Alto, California 94305
United States
NovaCure LLC
Miami, Florida 33176
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas 77030
United States
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas 77042
United States