Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)

Prior treatment

• Concurrent treatment with any other anti-neoplastic agents, including localized radiation therapy
• Participation in an interventional study of another investigational agent
• Prior therapies or diagnostics
• Active prior or concurrent malignancy: immunoglobulin),
• Receipt of live vaccine within the 30 days prior to the first dose o
• Major surgical procedure within 28 days of the first dose of LNTH-2403.

Other illness

• Known allergies, hypersensitivity, or intolerance to LNTH-2403 and/or its excipients
• Known active infection
• Known active liver disease from any cause, Hepatitis A Virus
• Known to be human immunodeficiency virus (HIV) positive
• Clinically relevant cardiovascular disease

Lab values

• 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
• Participant is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions

Other

• Participants meeting any of the following criteria will be excluded from the study
• A female participant who is pregnant or breastfeeding

• Histopathologic documented diagnosis of R/R osteosarcoma
• 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).
  • Measurable as defined in RECIST 1.1
  • Evaluable non-measurable disease as per RECIST 1.1
  • Bone only without a soft tissue component: must be 18F-FDG-PET avid and evaluable by serial 18F-FDG-PET imaging studies.
• 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.
• Performance Status:
  • Eastern Cooperative Oncology Group (ECOG) Performance Score (PS): 0 - 2
  • Lansky PS ≥ 50.
• Body weight: ≥ 30 kg.
• Tumor biopsies; Fresh or Archival
• Progression following at least one course of chemotherapy, which includes neoadjuvant / perioperative systemic therapy.
• All adverse events (AEs) related to prior therapies (chemotherapy / systemic therapies, radiation, surgery) must have resolved to Grade 1 or baseline
• Organ Function
• Pregnancy Women of Child-Bearing Potential (WOCBP) must have a negative serum pregnancy test result at screening
• Contraception- Male participants with a WOCBP partner must use 2 forms of acceptable contraception
• Written informed consent and/or assent must be obtained according to local guidelines and signed and dated by the participant, parent, and/or legal guardian prior to the performance of any study-specific procedures, sampling, or analyses