Study on Lu-TARGO Therapy for Relapsed or Refractory Osteosarcoma

Inclusion Criteria

• Have a confirmed diagnosis of relapsed or refractory osteosarcoma.
• The cancer must be measurable or evaluable by specific imaging techniques.
• Be at least 18 years old for the first group in Phase 1, and at least 12 years old for later groups and Phase 2.
• Be in relatively good health with a performance status score between 0 and 2.
• Weigh at least 30 kg (about 66 pounds).
• Provide a tumor biopsy sample, either fresh or from previous tests.
• Have experienced cancer progression after at least one chemotherapy treatment.
• Any side effects from previous treatments must have improved to a mild level.
• Have normal organ function based on medical tests.
• Women who can become pregnant must have a negative pregnancy test before starting the study.
• Male participants with partners who can become pregnant must use two forms of birth control.
• Agree to sign a consent form to participate in the study.

Exclusion Criteria

• Have allergies or intolerances to the study drug LNTH-2403 or its ingredients.
• Have any significant medical conditions that could affect safety or study results.
• Are receiving other cancer treatments, including radiation.
• Have an active infection.
• Are participating in another clinical trial.
• Have active liver disease or are HIV positive.
• Have significant heart disease.
• Have received a live vaccine within 30 days before starting the study.
• Are pregnant or breastfeeding.
• Have had major surgery within 28 days before starting the study.
• Are unable or unwilling to follow the study schedule and procedures.