NCT07357519 · Lantheus Medical Imaging
Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)
What this study is about
This is a multi-center, non-randomly assigned, where both patients and doctors know the treatment given, dosimetry and gradually increasing doses, group of participants-expansion study of LNTH-2403 administered to subjects with relapsed / refractory (R/R) osteosarcoma.
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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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must meet all the following criteria to be enrolled in the study
- 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
Exclusion criteria
- Participants meeting any of the following criteria will be excluded from the study
- Known allergies, hypersensitivity, or intolerance to LNTH-2403 and/or its excipients
- 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
- Concurrent treatment with any other anti-neoplastic agents, including localized radiation therapy
- Known active infection
- Participation in an interventional study of another investigational agent
- Prior therapies or diagnostics
- Active prior or concurrent malignancy: immunoglobulin),
- Known active liver disease from any cause, Hepatitis A Virus
- Known to be human immunodeficiency virus (HIV) positive
- Clinically relevant cardiovascular disease
- Receipt of live vaccine within the 30 days prior to the first dose o
- A female participant who is pregnant or breastfeeding
- Major surgical procedure within 28 days of the first dose of LNTH-2403.
- Participant is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions
Where
- Los Angeles, California
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations