Sarcoma Clinical Trial
Official title:
Phase 1 Trial With GD2-SADA:177Lu-DOTA Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, Sarcoma and Malignant Melanoma
NCT number | NCT05130255 |
Other study ID # | 1001 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | November 17, 2022 |
Est. completion date | April 2027 |
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
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 2027 |
Est. primary completion date | March 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
United States | Case Western Reserve University, Cleveland | Cleveland | Ohio |
United States | City of Hope National Medical Center | Duarte | California |
United States | Corewell Health-BAMF Health | Grand Rapids | Michigan |
United States | University of Wisconsin-Madison | Madison | Wisconsin |
United States | Memorial Sloan- Kettering Cancer Center | New York | New York |
United States | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania |
United States | HonorHealth | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Y-mAbs Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the optimal, safe GD2-SADA protein dose and dosing interval between GD2-SADA and 177Lu-DOTA administrations | Occurrence of DLTs (Part A) | 6 weeks | |
Primary | To determine maximum tolerable activity of 177Lu-DOTA | Occurrence of DLTs (Part B) | 6 weeks | |
Primary | 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) | Number and severity of adverse events (Part C) | 52 weeks |
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