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NCT03219268 · ClinicalTrials.gov registry record · Phase 1
A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms
A Phase 1 study, sponsored by MacroGenics.
- Completed
- Registry status
- Phase 1
- Development phase
- 277
- Enrollment target
NCT03219268 is a Phase 1 study that has completed, run by MacroGenics. The registered enrollment target is 277 participants.
The verdict
NCT03219268, a Phase 1 study, has completed, sponsored by MacroGenics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 277 participants
- Enrollment target
Study Summary
The primary goal of this Phase 1 study is to characterize the safety and tolerability of tebotelimab and establish the maximum tolerated dose (MTD) of tebotelimab in advanced solid tumors, and tebotelimab in combination with margetuximab in HER2+ advanced solid tumors. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of tebotelimab will also be assessed.
Interventions
- BIOLOGICAL tebotelimab 1 mg
- BIOLOGICAL tebotelimab 3 mg
- BIOLOGICAL tebotelimab 10 mg
- BIOLOGICAL tebotelimab 30 mg
- BIOLOGICAL tebotelimab 120 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 2017-08-18 |
| Est. Completion | 2023-02-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03219268
The ClinicalTrials.gov registry entry for NCT03219268 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 277 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MacroGenics, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which tebotelimab 1 mg is the first listed.
NCT03219268 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03219268 about?
NCT03219268 is a clinical study titled "A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms". The primary goal of this Phase 1 study is to characterize the safety and tolerability of tebotelimab and establish the maximum tolerated dose (MTD) of tebotelimab in advanced solid tumors, and tebotelimab in combination with margetuximab in HER2+ advanced solid tumors. Pharmacokinetics (PK), immunog...
What is the current status of trial NCT03219268?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 277 participants. The study started on 2017-08-18. Estimated completion is 2023-02-08.
What interventions are being tested in trial NCT03219268?
The interventions under investigation include: tebotelimab 1 mg (BIOLOGICAL), tebotelimab 3 mg (BIOLOGICAL), tebotelimab 10 mg (BIOLOGICAL), tebotelimab 30 mg (BIOLOGICAL), tebotelimab 120 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT03219268?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
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