Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LNTH2403 Phase 1 dose · 1 trial · 1 indication
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...
LNTH2403 is an investigational small molecule being studied for the treatment of relapsed or refractory osteosarcoma, a type of bone cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.
LNTH2403 is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker symbol LNTH. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with relapsed or refractory osteosarcoma.
LNTH2403 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is currently recruiting participants in the United States.
LNTH2403 is being evaluated in a Phase 1 clinical trial with the identifier NCT07357519, titled Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy). The trial is recruiting patients with relapsed or refractory osteosarcoma in the United States and has an enrollment target of 55 participants.
LNTH2403 is associated with the clinical trial Lu-TARGO, which stands for 177Lu-TARGeted Osteosarcoma Therapy. The trial name refers to the study of LNTH2403 in patients with relapsed or refractory osteosarcoma.