Safety Study of MGD009 in B7-H3-expressing Tumors
Public ClinicalTrials.gov record NCT02628535. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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 Neoplasms
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02628535
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 67 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2015 (Type not available)
- Primary completion
- Nov 25, 2019 (Actual)
- Completion
- Nov 25, 2019 (Actual)
- Last update posted
- Feb 8, 2022
2015 – 2019
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | — |
| Stanford University School of Medicine | Palo Alto | California | 94304 | — |
| University of California - San Francisco | San Francisco | California | 94143 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| New York University | New York | New York | 10016 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Carolina BioOncology Institute | Huntersville | North Carolina | 28078 | — |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Henry-Joyce Cancer Center | Nashville | Tennessee | 37232 | — |
| Mary Crowley Cancer Research Center | Dallas | Texas | 75230 | — |
| South Texas Accelerated Research Therapeutics, LLC | San Antonio | Texas | 78229 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22034 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02628535, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 8, 2022 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02628535 live on ClinicalTrials.gov.