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NCT03761017 · ClinicalTrials.gov registry record · Phase 1
MGD019 DART® Protein in Unresectable/Metastatic Cancer
A Phase 1 study, sponsored by MacroGenics.
- Completed
- Registry status
- Phase 1
- Development phase
- 162
- Enrollment target
NCT03761017: Completed Phase 1 study, sponsored by MacroGenics.
NCT03761017 is a Phase 1 study that has completed, run by MacroGenics. The registered enrollment target is 162 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (170% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03761017, a Phase 1 study, has completed, sponsored by MacroGenics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 162 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of lorigerlimab. This Phase 1, open-label study will characterize safety, dose-limiting toxicities (DLTs), and maximum tolerated/administered dose (MTD/MAD) of MGD019. Dose escalation will occur in a 3+3+3 design in patients with advanced solid tumors of any histology. Once the MTD/MAD is determined, a Cohort Expansion Phase will be enrolled to further characterize safety and initial anti-tumor activity in patients with specific tumor types anticipated to be sensitive to dual checkpoint blockade.
Primary Outcome
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 Lorigerlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2018-12-12 |
| Est. Completion | 2025-01-27 |
| Phase | Phase 1 |
What the finished NCT03761017 record still lists
NCT03761017 is an interventional study that assigns participants to a tested intervention. The registered 162 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 (170% higher).
The record links to 0 conditions, and to 1 intervention - of which Lorigerlimab is the first listed.
NCT03761017 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03761017 about?
NCT03761017 is a clinical study titled "MGD019 DART® Protein in Unresectable/Metastatic Cancer". The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of lorigerlimab. This Phase 1, open-label study will characterize safety, dose-limiting toxicities (DLTs), and maximum tolerated/administered dose (MTD/MAD...
What is the current status of trial NCT03761017?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 162 participants. The study started on 2018-12-12. Estimated completion is 2025-01-27.
What interventions are being tested in trial NCT03761017?
The interventions under investigation include: Lorigerlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03761017?
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 NCT03761017's enrollment target sits among peer trials
162 336th of 2000 higher than 1,661 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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