Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GD2-SADA:177Lu-DOTA Complex · 1 trial · 4 indications
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 \&...
GD2-SADA:177Lu-DOTA Complex is an investigational therapy being studied in patients with solid tumors known to express GD2, including small cell lung cancer (SCLC), malignant melanoma, sarcoma, and high risk neuroblastoma. It is in Phase 1 clinical development and has not been approved for any indication.
GD2-SADA:177Lu-DOTA Complex targets GD2, a disialoganglioside antigen expressed on the surface of several solid tumors. The complex is designed to deliver the radioisotope lutetium-177 (177Lu) to GD2-expressing tumor cells.
GD2-SADA:177Lu-DOTA Complex is being developed by Y-mAbs Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol YMAB.
GD2-SADA:177Lu-DOTA Complex is in Phase 1 clinical development. It is an investigational agent and has not received FDA approval.
GD2-SADA:177Lu-DOTA Complex is being evaluated in the Phase 1 trial NCT05130255, titled "GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2." The trial is currently recruiting and plans to enroll 60 participants across sites in the United States.