GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
- Conditions
- SCLCMalignant MelanomaSarcomaHigh Risk Neuroblastoma
- Registration Number
- NCT05130255
- Lead Sponsor
- Y-mAbs Therapeutics
- Brief 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine maximum tolerable activity of 177Lu-DOTA 6 weeks Occurrence of DLTs (Part B)
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) 52 weeks Number and severity of adverse events (Part C)
To determine the optimal, safe GD2-SADA protein dose and dosing interval between GD2-SADA and 177Lu-DOTA administrations 6 weeks Occurrence of DLTs (Part A)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Corewell Health-BAMF Health
🇺🇸Grand Rapids, Michigan, United States
Memorial Sloan- Kettering Cancer Center
🇺🇸New York, New York, United States
HonorHealth
🇺🇸Scottsdale, Arizona, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
University of Chicago
🇺🇸Chicago, Illinois, 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