Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)
A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, -Radiation Dosimetry, and Preliminary Anti-Neoplastic Activity of LNTH-2403, a LRRC15-targeted 177Lutetium-labeled Monoclonal Antibody, in Participants With Relapsed / Refractory Osteosarcoma
About This Trial
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 May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
LNTH2403 Phase 1 dose
LNTH-2403 administered once every 8 weeks, with the potential to explore other dosing schedules based on observed radiation dosimetry and PK parameters and safety and tolerability data.
Phase 2; LNTH2403 a single agent recommended phase 2 dose (RP2D).
Once the RP2D is selected, phase 2 will commence