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
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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
HonorHealth
Scottsdale, Arizona, United States
RECRUITINGCity of Hope National Medical Center
Duarte, California, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
To determine the optimal, safe GD2-SADA protein dose and dosing interval between GD2-SADA and 177Lu-DOTA administrations
Occurrence of DLTs (Part A)
Time frame: 6 weeks
To determine maximum tolerable activity of 177Lu-DOTA
Occurrence of DLTs (Part B)
Time frame: 6 weeks
To assess cumulative toxicity signals and safety profile (Number and severity of adverse events) following repeated dosing and determine the recommended phase 2 dose (RP2D)
Number and severity of adverse events (Part C)
Time frame: 52 weeks
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Corewell Health-BAMF Health
Grand Rapids, Michigan, United States
RECRUITINGMemorial Sloan- Kettering Cancer Center
New York, New York, United States
RECRUITINGCase Western Reserve University, Cleveland
Cleveland, Ohio, United States
RECRUITINGUPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
ACTIVE_NOT_RECRUITINGUniversity of Wisconsin-Madison
Madison, Wisconsin, United States
RECRUITING