Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)
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.
| Condition(s) | Relapsed / Refractory Osteosarcoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: Participants must meet all the following criteria to be enrolled in the study 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 |
| Ages | 12 Years |
| Sex | All |
| Lead sponsor | Lantheus Medical Imaging |
| Locations | Los Angeles, California, United States; Boston, Massachusetts, United States |
| Start date | 2026-02-03 |
| NCT ID | NCT07357519 |
| Official listing | https://clinicaltrials.gov/study/NCT07357519 |