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

NCT07357519•Lantheus Medical Imaging

View on ClinicalTrials.gov

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

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histopathologic documented diagnosis of R/R osteosarcoma
•2. Must have disease characterized by at least one of the following (Participants meeting only (b.), only (c.), or only (b. and c.) must be discussed with and receive written approval from the Sponsor to qualify).
•1. Measurable as defined in RECIST 1.1
•2. Evaluable non-measurable disease as per RECIST 1.1
•3. Bone only without a soft tissue component: must be 18F-FDG-PET avid and evaluable by serial 18F-FDG-PET imaging studies.
•3. Age: a. First Cohort in Phase 1: ≥ 18 years-of-age at the time of signature of the main study ICF. b. Second and subsequent cohorts, in Phase 1 and all participants in Phase 2: ≥12years-of-age at the time of signature of the main ICF.
•4. Performance Status:
•1. Eastern Cooperative Oncology Group (ECOG) Performance Score (PS): 0 - 2
•2. Lansky PS ≥ 50.
•5. Body weight: ≥ 30 kg.
+7 more criteria

Exclusion Criteria

•Participants meeting any of the following criteria will be excluded from the study
•1. Known allergies, hypersensitivity, or intolerance to LNTH-2403 and/or its excipients
•2. Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, may affect the participant's safety, compliance with the study, or otherwise impair the assessment of study results
•3. Concurrent treatment with any other anti-neoplastic agents, including localized radiation therapy
•4. Known active infection
•5. Participation in an interventional study of another investigational agent
•6. Prior therapies or diagnostics
•7. Active prior or concurrent malignancy: immunoglobulin),
•8. Known active liver disease from any cause, Hepatitis A Virus
•9. Known to be human immunodeficiency virus (HIV) positive
+5 more criteria

Locations (1)

UCLA

Los Angeles, California, United States

Key Dates

Start Date

February 1, 2026

Primary Completion Date

August 1, 2027

Completion Date

May 1, 2032

Last Updated

February 9, 2026

Enrollment

ESTIMATED participants

Conditions

Relapsed / Refractory Osteosarcoma

Interventions

LNTH2403 Phase 1 dose

DRUG

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

DRUG

Contacts

Kerri Sforzo

CONTACT

978-671-8886 clinicaltrials@lantheus.com