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

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with Small Cell Lung Cancer, 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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Y-mAbs Therapeutics

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 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