Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07357519 | Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy) | PHASE1 | RECRUITING | 55 | — | — | Feb 3, 2026 | May 1, 2032 | May 1, 2026 | 2 | United States |
Incidence of DLTs during the first 8 weeks (DLT evaluation window) after the first dose of LNTH-2403
Type, frequency, severity, timing, and relationship to LNTH-2403 of all Treatment-emergent adverse event, (TEAEs) and Serious adverse events, (SAEs)
Event-Free Survival (EFS) at 4 months
| Arm | Type | Description |
|---|---|---|
| Phase 1- Escalating doses of LNTH-2403 administered once every 8 weeks | EXPERIMENTAL | Phase 1 will evaluate escalating doses of 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 will evaluate LNTH-2403 as a single agent at the recommended phase 2 dose | EXPERIMENTAL | Phase 2 will evaluate LNTH-2403 as a single agent in participants with R/R osteosarcoma at the recommended phase 2 dose (RP2D). |
| Name | Type | Description |
|---|---|---|
| LNTH2403 Phase 1 dose | DRUG | 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). | DRUG | Once the RP2D is selected, phase 2 will commence |
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 d...