Last updated on August 2018

Safety Study of MGD009 in B7-H3-expressing Tumors


Brief description of study

The purpose of this study is to evaluate the safety of MGD009 when given to patients with B7-H3-expressing tumors. The study will also evaluate what is the highest dose of MGD009 that can be given safely. Assessments will be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate potential anti-tumor activity of MGD009.

Detailed Study Description

This study is a Phase 1 open-label, dose escalation, cohort expansion, and efficacy follow-up study of MGD009 administered intravenously (IV) on an every-other-week schedule for up to one year (14 cycles).

The dose escalation phase is designed to characterize the safety and tolerability of MGD009 and to define the maximum tolerated or maximum administered dose (MTD/MAD). This phase will enroll patients with mesothelioma, bladder cancer, melanoma, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC), ovarian cancer, thyroid cancer, triple-negative breast cancer (TNBC), pancreatic cancer, colon cancer, soft tissue sarcoma, or prostate cancer.

In the cohort expansion phase, 6 cohorts of 16 patients each will be enrolled to further evaluate the safety and potential efficacy of MGD009 administered at the MTD/MAD dose in patients with mesothelioma, bladder cancer, melanoma, SCCHN, NSCLC, or other specific tumors that express high levels of B7-H3. Pre- and on-study biopsies are required for melanoma patients in the cohort expansion phase.

The survival follow-up phase consists of the 2-year period after the final dose of study drug.

All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC).

Clinical Study Identifier: NCT02628535

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Shivaani Kummar, MD, FACP

Stanford University School of Medicine
Palo Alto, CA United States
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Lawrence Fong, MD

University of California - San Francisco
San Francisco, CA United States
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Gregory Cote, MD

Massachusetts General Hospital
Boston, MA United States
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F. Stephen Hodi, MD

Dana Farber Cancer Institute
Boston, MA United States
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Luca Paoluzzi, MD

New York University
New York, NY United States
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John D. Powderly, M.D.

Carolina BioOncology Institute
Huntersville, NC United States
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Evan Alley, M.D.

Penn Presbyterian Medical Center
Philadelphia, PA United States
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James Strauss, MD

Mary Crowley Cancer Research Center
Dallas, TX United States
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Anthony Tolcher, M.D.

South Texas Accelerated Research Therapeutics, LLC
San Antonio, TX United States
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Alexander Spira, MD

Virginia Cancer Specialists
Fairfax, VA United States
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Geoffrey Gibney, MD

Georgetown University
Washington, WA United States
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Bing Nie

Columbia University Medical Center
New York, NY United States
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