RECRUITINGPhase 1INTERVENTIONAL
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
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
- Signed willing to sign a consent form 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 willing to sign a consent form, for High Risk Neuroblastoma \& sarcoma age ≥16 years of age at time of willing to sign a consent form/assent
- Measurable disease according to RECIST 1.1
- You should be able to carry out daily activities with 0 level of ability (ECOG 0)-1
- Expected survival \>3 months
- Platelet counts ≥100,000 cells/mm3
- blood count (hemoglobin) at least 9 g/dL
- Adequate renal function with serum creatinine ≤1.5 mg/dL or kidney function (creatinine clearance) at least 60mL/min as calculated using the Cockcroft-Gault equation
- Patient willing and able to comply with the trial protocol
Who Should NOT Join This Trial:
- 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 conditions (where your immune system attacks your own body)s or immunodeficiencies or documented infection with human weakened immune system virus (HIV) or hepatitis B or C virus (active)
- Prior treatment with anti-GD2 antibody
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 \& 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 Criteria:
* 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
Treatments Being Tested
DRUG
GD2-SADA:177Lu-DOTA Complex
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)
HonorHealth
Scottsdale, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
University of Chicago
Chicago, Illinois, United States
Corewell Health-BAMF Health
Grand Rapids, Michigan, United States
Memorial Sloan- Kettering Cancer Center
New York, New York, United States
Case Western Reserve University, Cleveland
Cleveland, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States