Overview

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