GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Phase 1 Trial With GD2-SADA:177Lu-DOTA Drug Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma
Y-mAbs Therapeutics
60 participants
Nov 17, 2022
INTERVENTIONAL
Conditions
Summary
Patients with Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma will be treated with GD2-SADA:177Lu-DOTA complex(The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA) to assess safety and tolerability
Eligibility
Inclusion Criteria9
- 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 \& sarcoma age ≥16 years of age at time of informed consent/assent
- Measurable disease according to RECIST 1.1
- ECOG performance status 0-1
- Expected survival \>3 months
- Platelet counts ≥100,000 cells/mm3
- Hemoglobin ≥9 g/dL
- Adequate renal function with serum creatinine ≤1.5 mg/dL or creatinine clearance ≥60mL/min as calculated using the Cockcroft-Gault equation
- Patient willing and able to comply with the trial protocol
Exclusion Criteria5
- Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the IMP per protocol
- Patients receiving any other investigational therapy for their cancer within 3 weeks prior to the first planned dosing of the IMP per protocol
- Ongoing radiation toxicities from prior RT therapy
- Patients with a diagnosis of autoimmune diseases or immunodeficiencies or documented infection with human immunodeficiency virus (HIV) or hepatitis B or C virus (active)
- Prior treatment with anti-GD2 antibody
Interventions
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
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT05130255