Neuroblastoma Clinical Trial
Official title:
A Phase 1, Open-label, Dose Escalation Study of MGA271 in Pediatric Patients With B7-H3-Expressing Relapsed or Refractory Solid Tumors
Verified date | February 2022 |
Source | MacroGenics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses (approximately 2 years) in children and young adults with B7-H3-expressing relapsed or refractory malignant solid tumors.
Status | Completed |
Enrollment | 25 |
Est. completion date | May 22, 2019 |
Est. primary completion date | May 22, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 35 Years |
Eligibility | General Inclusion Criteria: - Age at treatment 1 to 35 years. - Relapsed or refractory malignant solid tumors of any histology for which no standard curative therapy is available (escalation phase). - Histologically proven: neuroblastoma, rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma/ primitive neuroectodermal tumor, Wilms tumor, desmoplastic small round cell tumor or malignant solid tumors of any other histology that test positive for B7-H3 . - Must have malignant solid tumors that demonstrate B7-H3 expression at 2+ or greater levels on the membranous surface of at least 10% of tumor cells or = 25% of tumor vasculature by IHC. - With the exception of patients with non-measurable neuroblastoma patients must have measurable disease as per RECIST 1.1 - Karnofsky (patients = 16 years)/Lansky (patients < 16 years) index = 70. - Acceptable laboratory parameters and adequate organ reserve. Exclusion Criteria: - Patients are to be excluded from the study if they have any of the following: - Patients with a history of symptomatic central nervous system (CNS) unless they have been treated and are asymptomatic. - Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment within the past 2 years, and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing. - History of prior allogeneic bone marrow/stem-cell or solid organ transplantation. - Patients receiving autologous stem cell transplantation must wait 8 weeks before initiation of study drug administration. - Treatment with systemic chemotherapy or investigational therapy within 4 weeks of first study drug administration; other agents (e.g., biologics) within 2 weeks; radiation within 2 weeks; patients receiving 131I-MIBG therapy must wait 6 weeks prior to the initiation of study drug administration; corticosteroids (= 0.2 mg/kg/day prednisone or equivalent) or other immune suppressive drugs within the 2 weeks prior to the initiation of study drug administration. - History of clinically significant cardiovascular disease - Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. - Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome. - Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction. - Second primary invasive malignancy that has not been in remission for greater than 2 years. - History of severe trauma or major surgery within 4 weeks prior to the initiation of study drug administration. - Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient contained in the drug formulation for enoblituzumab - Patients in Canada may not have a history or evidence of latent or active tuberculosis infection. |
Country | Name | City | State |
---|---|---|---|
United States | National Cancer Institute, Center for Cancer Research | Bethesda | Maryland |
United States | Texas Children's Hospital | Houston | Texas |
United States | University of Wisconsin, American Family Children's Hospital | Madison | Wisconsin |
United States | Lucile Packard Children's Hospital, Stanford | Palo Alto | California |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Seattle Children's | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
MacroGenics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability of enoblituzumab. | Adverse events, SAEs, incidence of treatment-emergent AE | Time of first dose through end of treatment (up to 2 years) | |
Secondary | Peak plasma concentration | PK of enoblituzumab | Time of first dose through end of treatment (up to 96 weeks) | |
Secondary | Number of participants that develop anti-drug antibodies | Proportion of patients who develop anti-MGA271 antibodies, immunogenicity | Time of first dose through end of treatment (up to 96 weeks) | |
Secondary | Antitumor activity of enoblituzumab | Anti-tumor activity of enoblituzumab using conventional RECIST 1.1 and immune related RECIST criteria | Time of first dose through end of treatment (up to 96 weeks) |
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