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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: Completed Phase 1 study, sponsored by MacroGenics.
NCT03219268 is a Phase 1 study that has completed, run by MacroGenics. The registered enrollment target is 277 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (362% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
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 |
What the finished NCT03219268 record still lists
NCT03219268 is an interventional study that assigns participants to a tested intervention. The registered 277 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (362% higher).
The record links to 0 conditions, and to 5 interventions - of which tebotelimab 1 mg is the first listed.
NCT03219268 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03219268's enrollment target sits among peer trials
277 147th of 2000 higher than 1,853 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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