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Protocol No. UW16107

Principal Investigator DeSantes, Kenneth

Phase I

Age Group Both

Scope National

Sponsor Type Industry

Title A Phase 1, Open-label, Dose Escalation Study of MGA271 in Pediatric Patients with B7-H3-Expressing Relapsed or Refractory Solid Tumors

Objective This study involves research about MGA271. MGA271 targets cancer cells that make too much of a protein called B7-H3. Another way to say it is that the cells "overexpress" the protein. Too much of this protein may allow the cancer cell to not be seen by the immune systemn, which allows it to grow faster.

Treatment MGA271 is an investigational drug which means the drug has not been approved by any government office that regulates new medicines. This includes the U.S. Food and Drug Administration (FDA). MGS271 targets cancer cells that make too much of a protein called B7-H3. It is given once a week, every week, while you are on study. The test drug will be given through a thin plastic tube that is placed into the vein of your arm or through the central venous catheter. This procedure is called an IV infusion.

Description This study will take place in two phases - the dose escalation phase and the cohort expansion phase. The purpose of the dose escalation phase is to find out what is the highest single dose that can be given without causing significant side effects. In the cohort expansion phase, participants will be treated to better determine the effects of giving the highest single dose of MGA271 that did not cause any unacceptable side effects during the dose escalation phase. Each participant will remain in the study for up to 2 years if there are no severe side effects of treatment and the cancer is not growing rapidly on treatment. Patients will receive MGA271 every week for about 2 years.

Key Eligibility
  • Age ≥ 1 to 35 years at diagnosis of primary tumor (treatment up to the age of 30 years old)
  • Relapsed or refractory malignant solid tumors of any histology for which no standard curative therapy is available (escalation phase). Expansion phase will be limited to histologically proven neuroblastoma, rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma, Wilms tumor or desmoplastic small round cell tumor
  • Patients must have malignant solid tumors that demonstrate B7-H3 expression
  • Patients with a history of symptomatic central nervous system (CNS) metastases or symptomatic skull base lesions, are excluded, 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
  • Patients with a history of asthma will NOT be excluded, provided the asthma is well controlled
  • Patients with a 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
  • Patients receiving myelosuppressive chemotherapy must wait 4 weeks before initiation of study drug administration. Patients receiving other agents (e.g., biologics) must wait 2 weeks before initiation of study drug administration
  • Patients receiving focal radiation therapy must wait 2 weeks prior to the initiation of study drug administration
  • Patients with a known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome, known history of hepatitis B or hepatitis C infection are ineligible
  • Patients who have had a vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration are ineligible. Inactivated annual influenza vaccination is allowed

Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Kidney; Liver; Lung; Melanoma/Skin cancer; Neuroblastoma; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Testicular; Thyroid; Uterus; Vagina; Vulva

Therapies Involved Immunotherapy

Drugs Involved MGA271

Status Open

Participating Institutions UW Hospital and Clinics