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
A phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial of the safety and tolerability of GD2-SADA:177Lu-DOTA complex in GD2 expressing solid tumors. The trial is planned as a Phase 1 trial with three parts, A, B and C. Escalation in this trial will be based on a classical 3+3 trial design. Part A is a GD2-SADA dose escalation phase, in which patients will receive one treatment cycle. Part B is a 177Lu-DOTA dose escalation phase, in which patients will receive up to 2 treatment cycles . Part C is a repeated dosing phase where the doses determined in Part A and B will be administered. Patients will receive repeated treatment cycles with a maximum of 5 cycles.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
23
GD2-SADA IV at 0.3 mg/kg followed by 30 mCi 177Lu-DOTA IV
GD2-SADA IV at 3 mg/kg followed by 30 mCi 177 Lu-DOTA
GD2-SADA 0.3 mg/kg followed by 200 mCi 177 Lu-DOTA
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
Number of Participants With Dose Limiting Toxicity
Adverse events meeting the criteria of a dose limiting toxicity are graded according to CTCAE version 5
Time frame: Within 6 weeks after first IMP administration
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GD2-SADA 1 mg/kg followed by 200 mCi 177 Lu-DOTA
GD2-SADA 3 mg/kg followed by 200 mCi 177 Lu-DOTA
GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA
GD2-SADA (1 mg/kg) followed by 177Lu-DOTA (100 mCi)
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