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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
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.
Once the RP2D is selected, phase 2 will commence
UCLA
Los Angeles, California, United States
RECRUITINGTo 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
To assess the preliminary anti-neoplastic activity of LNTH-2403 in participants with R/R osteosarcoma (Ph1)
Event-Free Survival (EFS) at 8 weeks
Time frame: 8 weeks
To describe the safety and tolerability profile of LNTH-2403 in participants with R/R osteosarcoma (Ph2)
Type, frequency, severity, timing, and relationship to LNTH-2403 of any TEAEs and SAEs
Time frame: 4 months
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