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 is being developed by Y-mAbs Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol YMAB. The company is conducting clinical research to evaluate this investigational therapy in patients with GD2-expressing solid tumors.
GD2-SADA:177Lu-DOTA Complex is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is actively recruiting participants to evaluate the safety and tolerability of this therapy.
GD2-SADA:177Lu-DOTA Complex is being studied in a Phase 1 clinical trial with the identifier NCT05130255. This trial is titled 'GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2' and is currently recruiting participants in the United States.
GD2-SADA:177Lu-DOTA Complex is designed to target GD2, a molecule expressed on certain solid tumors. The drug is being studied in patients with tumors known to express GD2, including small cell lung cancer, melanoma, sarcoma, and neuroblastoma. The trial is biomarker-selected, meaning patients are chosen based on GD2 expression.