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 small molecule being studied for the treatment of small cell lung cancer (SCLC). It is also being evaluated in patients with other solid tumors known to express GD2, including malignant melanoma, sarcoma, and high risk neuroblastoma.
GD2-SADA:177Lu-DOTA Complex targets GD2, a tumor-associated antigen expressed on certain solid tumors. The drug is designed to deliver a radioactive payload (177Lu) to GD2-expressing cancer cells, potentially enabling targeted radiotherapy.
GD2-SADA:177Lu-DOTA Complex is being developed by Y-mAbs Therapeutics, Inc., a biopharmaceutical company traded on 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 been approved by the FDA. The ongoing Phase 1 trial is actively recruiting participants.
GD2-SADA:177Lu-DOTA Complex is being studied in a single Phase 1 clinical trial, NCT05130255, titled 'GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2.' The trial is recruiting in the United States and aims to enroll 60 patients aged 16 years and older.
GD2-SADA:177Lu-DOTA Complex is a specific investigational construct that combines a GD2-targeting SADA (Self-Assembling and Disassembling) protein with a 177Lu-DOTA radioactive payload. It is distinct from other 177Lu-DOTA-based agents and is being developed by Y-mAbs Therapeutics.