Actively Recruiting
Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)
Led by Lantheus Medical Imaging · Updated on 2026-05-01
55
Participants Needed
2
Research Sites
325 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory osteosarcoma confirmed by pathology
- Disease measurable by RECIST 1.1 or evaluable non-measurable disease, or bone-only disease with PET imaging
- Age 18 years or older for first Phase 1 cohort; 12 years or older for subsequent cohorts and Phase 2
- Performance status of 0 to 2 on ECOG scale or Lansky score 50 or higher
- Body weight of at least 30 kg
- Availability of fresh or archival tumor biopsies
- Disease progression after at least one chemotherapy course including neoadjuvant or perioperative therapy
- All side effects from prior treatments resolved to Grade 1 or baseline
- Adequate organ function
- Negative pregnancy test for women of childbearing potential
- Male participants with female partners of childbearing potential must use two forms of contraception
- Signed informed consent or assent obtained before any study procedures
You will not qualify if you...
- Allergy or intolerance to LNTH-2403 or its ingredients
- Significant ongoing illness or medical condition that may affect safety or study compliance
- Current treatment with other anti-cancer agents or radiation therapy
- Active infection
- Participation in another investigational drug study
- Prior therapies or diagnostics that interfere with this study
- Active or prior other malignancies
- Active liver disease including Hepatitis A
- Known HIV infection
- Significant cardiovascular disease
- Received live vaccine within 30 days before first dose
- Pregnant or breastfeeding women
- Major surgery within 28 days before first dose
- Unable or unwilling to follow study visits, treatment plan, tests, or restrictions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
K
Kerri Sforzo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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