NCT07505771

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

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Immunome, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Malignancies

Interventions

Type	Name	Description
DRUG	177Lu-IM-3050	177Lu-IM-3050 is a FAP-directed radiopharmaceutical

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-12-01
• Completion: 2034-12-01
• First posted: 2026-04-01
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study