GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2

Launched by Y-MABS THERAPEUTICS · Nov 11, 2021

Keywords

ClinConnect Summary

The GD2-SADA:177Lu-DOTA clinical trial is studying a new treatment for patients with certain types of solid tumors, including Small Cell Lung Cancer, Malignant Melanoma, Sarcoma, and High-Risk Neuroblastoma. This treatment involves a two-step process using a special compound that combines a targeted approach with radiation to help fight the cancer. The main goal of the trial is to evaluate how safe and tolerable this treatment is for patients.

To participate in this trial, patients generally need to be at least 16 or 18 years old, have measurable cancer that meets specific criteria, and have a good performance status, meaning they can carry out daily activities without much difficulty. Participants should also expect to be monitored closely throughout the study to ensure their safety. It’s important to note that patients who have recently received other cancer treatments or have certain health conditions may not be eligible. If you or a loved one is considering joining this trial, it could be a chance to access a new treatment option while contributing to important research.

Gender

ALL

Eligibility criteria

• 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