Actively Recruiting
Phase 1 Trial of GD2-SADA:177Lu-DOTA Drug Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Expressing GD2 Including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma, and Malignant Melanoma
Led by Y-mAbs Therapeutics · Updated on 2024-10-02
60
Participants Needed
8
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of the GD2-SADA:177Lu-DOTA complex in patients with solid tumors known to express GD2, including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma, and Malignant Melanoma. This phase 1, open-label, non-randomized trial uses a dose-escalation design to find the optimal dosing of this two-step radioimmunotherapy. The study is conducted across multiple centers and aims to establish safe dosage levels and assess adverse effects in these cancer patients. The treatment involves two products delivered intravenously: GD2-SADA followed by 177Lu-DOTA. The trial has three parts: Part A escalates the GD2-SADA dose with one treatment cycle; Part B escalates the 177Lu-DOTA dose with up to two treatment cycles; and Part C administers repeated dosing at the established safe doses with up to five cycles. Each cycle includes administration of both GD2-SADA and 177Lu-DOTA. Participants will undergo regular assessments to monitor safety and tolerability, including adverse event tracking. The primary outcomes include determining the optimal GD2-SADA dose and timing between the two infusions over six weeks, establishing the maximum tolerable activity of 177Lu-DOTA, and assessing cumulative toxicity and safety over up to 52 weeks. The study duration allows for repeated dosing and thorough safety evaluation in patients with recurrent or refractory metastatic GD2-expressing tumors.
CONDITIONS
Brief Title
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent obtained according to local regulations
- Age 18 years or older at consent, or 16 years or older for High Risk Neuroblastoma and Sarcoma
- Measurable disease according to RECIST 1.1 criteria
- ECOG performance status 0 or 1
- Expected survival greater than 3 months
- Platelet count of at least 100,000 cells/mm3
- Hemoglobin level of 9 g/dL or higher
- Adequate kidney function with serum creatinine 1.5 mg/dL or below or creatinine clearance of at least 60 mL/min
- Willing and able to comply with trial protocol
You will not qualify if you...
- Received systemic chemotherapy, radiotherapy, immunotherapy, or major surgery within 3 weeks before first dosing
- Receiving any other investigational cancer therapy within 3 weeks before first dosing
- Ongoing toxicities from prior radiation therapy
- Diagnosis of autoimmune diseases or immunodeficiencies
- Active infection with HIV or hepatitis B or C virus
- Prior treatment with anti-GD2 antibody
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 52 weeks
Participants receive the GD2-SADA:177Lu-DOTA drug complex through intravenous infusions in treatment cycles. Part A includes 1 treatment cycle for GD2-SADA dose escalation. Part B includes up to 2 treatment cycles for 177Lu-DOTA dose escalation. Part C involves repeated treatment cycles with a maximum of 5 cycles at the recommended doses determined in earlier parts.
Multiple treatment cycles with visits corresponding to each infusion
Trial Site Locations
Total: 8 locations
1
HonorHealth
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
University of Chicago
Chicago, Illinois, United States, 60637
Not Yet Recruiting
4
Corewell Health-BAMF Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
5
Memorial Sloan- Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
6
Case Western Reserve University, Cleveland
Cleveland, Ohio, United States, 44106
Actively Recruiting
7
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15260
Active, Not Recruiting
8
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
J
Joris Wilms
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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