RecruitingPhase 1Phase 2NCT07357519

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


Sponsor

Lantheus Medical Imaging

Enrollment

55 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted radiation therapy called Lu-TARGO for people with osteosarcoma (a type of bone cancer) that has come back or stopped responding to treatment. The therapy uses a radioactive substance that zeroes in on cancer cells to destroy them. **You may be eligible if...** - You have been diagnosed with osteosarcoma that has relapsed or is no longer responding to treatment - You are at least 12 years old (or 18 for the first group in Phase 1) - You weigh at least 30 kg (about 66 lbs) - Your cancer is measurable on scans or visible on PET imaging - Your cancer has progressed after at least one course of chemotherapy - You are well enough to perform basic daily activities (performance score of 0–2) **You may NOT be eligible if...** - You are currently receiving other anti-cancer treatments - You have HIV, active hepatitis, or other active serious infections - You are pregnant or breastfeeding - You have significant heart problems - You had major surgery within the past 28 days - You have a known allergy to the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLNTH2403 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.

DRUGPhase 2; LNTH2403 a single agent recommended phase 2 dose (RP2D).

Once the RP2D is selected, phase 2 will commence


Locations(2)

UCLA

Los Angeles, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT07357519