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

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

Interventions

• Drug
  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.

• Drug
  Phase 2; LNTH2403 a single agent recommended phase 2 dose (RP2D).

  Once the RP2D is selected, phase 2 will commence

Locations (2)