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
Lantheus Medical Imaging
Summary
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.
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants must meet all the following criteria to be enrolled in the study 1. Histopathologic documented diagnosis of R/R osteosarcoma 2. 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). 1. Measurable as defined in RECIST 1.1 2. Evaluable non-measurable disease as per RECIST 1.1 3. Bone only without a soft tissue component: must be 18F-FDG-PET avid and evaluable by serial 18F-FDG-PET imaging studies.…
Interventions
- DrugLNTH2403 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.
- DrugPhase 2; LNTH2403 a single agent recommended phase 2 dose (RP2D).
Once the RP2D is selected, phase 2 will commence
Locations (2)
- UCLALos Angeles, California
- Dana Farber Cancer InstituteBoston, Massachusetts