GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Study Details
Study Description
Brief 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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: GD2-SADA:177Lu-DOTA Complex GD2-SADA IV. infusion followed by 177Lu-DOTA IV. infusion (The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA ). 1 treatment cycle in Part A, 2 treatment cycles in Part B and up to 5 treatment cycles in Part C |
Drug: GD2-SADA:177Lu-DOTA Complex
The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA, both will be administered as an IV infusion
Other Names:
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Outcome Measures
Primary Outcome Measures
- To determine the optimal, safe GD2-SADA protein dose and dosing interval between GD2-SADA and 177Lu-DOTA administrations [6 weeks]
Occurrence of DLTs (Part A)
- To determine maximum tolerable activity of 177Lu-DOTA [6 weeks]
Occurrence of DLTs (Part B)
- To assess cumulative toxicity signals and safety profile (Number and severity of adverse events) following repeated dosing and determine the recommended phase 2 dose (RP2D) [52 weeks]
Number and severity of adverse events (Part C)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Age ≥18 years at the time of informed consent, for sarcoma age ≥16 years of age at time of informed consent/assent
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Measurable disease according to RECIST 1.1
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ECOG performance status 0-1
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Expected survival >3 months
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Platelet counts ≥100,000 cells/mm3
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Hemoglobin ≥9 g/dL
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Adequate renal function with serum creatinine ≤1.5 mg/dL or creatinine clearance ≥60mL/min as calculated using the Cockcroft-Gault equation
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Patient willing and able to comply with the trial protocol
Exclusion Criteria:
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Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the IMP per protocol
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Patients receiving any other investigational therapy for their cancer within 3 weeks prior to the first planned dosing of the IMP per protocol
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Ongoing radiation toxicities from prior RT therapy
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Patients with a diagnosis of autoimmune diseases or immunodeficiencies or documented infection with human immunodeficiency virus (HIV) or hepatitis B or C virus (active)
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Prior treatment with anti-GD2 antibody
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Y-mAbs Therapeutics
Investigators
- Principal Investigator: Taofeek K Owonikoko, MD/PhD, UPMC Hillman Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1001