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MGA271


Title A Phase 1, Open Label, Dose Escalation Study of MGA271 (Fcoptimized Humanized Anti-B7-H3 Monoclonal Antibody) in Patients with Refractory B7-H3-Expressing Neoplasms or Neoplasms Whose Vasculature Expresses B7-H3
Therapeutic Area Breast Cancer
Principal Investigator John Erban, MD
Min Age 18 Years
Gender Female
Contact Maddie Arthur
617-636-7651
More Information https://clinicaltrials.gov/ct2/show/NCT01391143

Overview

The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV) infusion to patients with refractory cancer. The study will also evaluate how long MGA271 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it may have an effect on tumors.

Study Details

Inclusion Criteria

  • Patients with prostate cancer, renal cell carcinoma, head and neck cancer, triple-negative breast cancer, bladder cancer, non-small cell lung cancer or melanoma that overexpresses B7-H3.
  • Progressive disease during or after last treatment regimen.

Exclusion Criteria

  • Major surgery or trauma within four weeks before enrollment.
  • Vaccination within 2 weeks of enrollment (except for annual flu vaccine).

Study Requirements

In the plan for this study, patients will have about 11 study visits and their participation in this study will last at least 12 weeks. It will take up to 4 weeks to see if you are eligible to join. Then you will receive MGA271 every week on days 1, 8, 15, 22, 29, 36, 43 and 50 of each 8-week cycle. If the cancer improves or is stable after the first 8 weeks of study drug, then the study doctor may suggest they receive more 8-week cycles of test drug. You will have physical exams, blood tests, CT or MRI scans, ECGs and other study procedures as per protocol.