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.
Arms & 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
Outcome measures
Primary
To identify the maximum tolerated dose (MTD) of LNTH-2403 in participants with R/R osteosarcoma (Ph1)
Incidence of DLTs during the first 8 weeks (DLT evaluation window) after the first dose of LNTH-2403
Time frame: From enrollment to the end of treatment at 8 weeks
To evaluate the safety and tolerability profile of LNTH-2403 in participants with R/R osteosarcoma (Ph1)
Type, frequency, severity, timing, and relationship to LNTH-2403 of all Treatment-emergent adverse event, (TEAEs) and Serious adverse events, (SAEs)
Time frame: From enrollment to the end of treatment at 8 weeks
To assess the preliminary anti-neoplastic activity of LNTH-2403 in participants with R/R osteosarcoma (Ph2)
Event-Free Survival (EFS) at 4 months
Time frame: From enrollment to Event-Free Survival (EFS) at 4 months
Secondary
To assess the preliminary anti-neoplastic activity of LNTH-2403 in participants with R/R osteosarcoma (Ph1)
Time frame: 8 weeks
To describe the safety and tolerability profile of LNTH-2403 in participants with R/R osteosarcoma (Ph2)
Time frame: 4 months
Eligibility criteria
Study locations (2)
UCLA
Los Angeles, California, 90095
Dana Farber Cancer Institute
Boston, Massachusetts, 02115