NCT07357519

Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, -Radiation Dosimetry, and Preliminary Anti-Neoplastic Activity of LNTH-2403, a LRRC15-targeted 177Lutetium-labeled Monoclonal Antibody, in Participants With Relapsed / Refractory Osteosarcoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Lantheus Medical Imaging · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, non-randomized, open-label, dosimetry and dose-escalation, cohort-expansion study of LNTH-2403 administered to subjects with relapsed / refractory (R/R) osteosarcoma. This study consists of 2 phases: (1) a dosimetry and dose escalation phase; and (2) a cohort expansion phase.

Conditions

• Relapsed / Refractory Osteosarcoma

Interventions

Type	Name	Description
DRUG	LNTH2403 Phase 1 dose	LNTH-2403 administered once every 8 weeks, with the potential to explore other dosing schedules based on observed radiation dosimetry and PK parameters and safety and tolerability data.
DRUG	Phase 2; LNTH2403 a single agent recommended phase 2 dose (RP2D).	Once the RP2D is selected, phase 2 will commence

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-08-01
• Completion: 2032-05-01
• First posted: 2026-01-22
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study