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Safety Study of MGD009 in B7-H3-expressing Tumors

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Contents

clinicaltrials.gov/study/NCT02628535
Is a
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Clinical study
0

Clinical Study attributes

NCT Number
NCT026285350
Health Conditions in Trial
Prostate cancer
Prostate cancer
0
Clear cell renal cell carcinoma
Clear cell renal cell carcinoma
0
Thyroid cancer
Thyroid cancer
0
‌
Breast Cancer
0
Melanoma
Melanoma
0
Ovarian cancer
Ovarian cancer
0
Pancreatic cancer
Pancreatic cancer
0
Mesothelioma
Mesothelioma
0
...
Trial Recruitment Size
670
Trial Sponsor
MacroGenics
MacroGenics
0
Clinical Trial Start Date
2015
0
Primary Completion Date
November 25, 2019
0
Study Completion Date
November 25, 2019
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Biological0
Intervention Name
MGD0090
Interventional Trial Phase
Phase 10
Participating Facility
Columbia University Medical Center
Columbia University Medical Center
0
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Linear Clinical Research
0
‌
Chris O'Brien Lifehouse
0
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Carolina Biooncology Institute
0
New York University
New York University
0
Georgetown University
Georgetown University
0
Stanford University School of Medicine
Stanford University School of Medicine
0
Princess Margaret Cancer Centre
Princess Margaret Cancer Centre
0
...
Official Name
Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients With Unresectable or Metastatic B7-H3-Expressing Neoplasms0
Last Updated
February 8, 2022
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study summary

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.

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