Lung Cancer Clinical Trial
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
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
Full 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.
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 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
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