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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05130255 | GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2 | PHASE1 | RECRUITING | 60 | — | — | Nov 17, 2022 | Apr 1, 2027 | Oct 2, 2024 | 8 | United States |
Occurrence of DLTs (Part A)
Occurrence of DLTs (Part B)
Number and severity of adverse events (Part C)
| Arm | Type | Description |
|---|---|---|
| GD2-SADA:177Lu-DOTA Complex | EXPERIMENTAL | GD2-SADA IV. infusion followed by 177Lu-DOTA IV. infusion (The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA ). 1 treatment cycle in Part A, 2 treatment cycles in Part B and up to 5 treatment cycles in Part C |
| Name | Type | Description |
|---|---|---|
| GD2-SADA:177Lu-DOTA Complex | DRUG | The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA, both will be administered as an IV infusion |
Inclusion Criteria: * Signed informed consent from patient, legal guardian(s) and/or adolescents obtained in accordance with local regulations. Pediatric patients must provide assent as required by local regulations. * Age ≥18 years at the time of informed consent, for High Risk Neuroblastoma \&...