Enoblituzumab (MGA271) in Children With B7-H3-expressing Solid Tumors
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Enoblituzumab
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.
Ages Eligible for Study
1 Year - 35 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Nancy Sweeters
650-721-4074
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.