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NCT03059823 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 325
- Enrollment target
NCT03059823: Completed Phase 1 study, sponsored by Incyte Corporation.
NCT03059823 is a Phase 1 study that has completed, run by Incyte Corporation. The registered enrollment target is 325 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (442% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03059823, a Phase 1 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 325 participants
- Enrollment target
Study Summary
The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed. The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort.
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
- DRUG retifanlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2016-11-15 |
| Est. Completion | 2024-05-22 |
| Phase | Phase 1 |
What the finished NCT03059823 record still lists
NCT03059823 is an interventional study that assigns participants to a tested intervention. The registered 325 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 (442% higher).
The record links to 0 conditions, and to 1 intervention - of which retifanlimab is the first listed.
NCT03059823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03059823 about?
NCT03059823 is a clinical study titled "A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors". The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, ...
What is the current status of trial NCT03059823?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 325 participants. The study started on 2016-11-15. Estimated completion is 2024-05-22.
What interventions are being tested in trial NCT03059823?
The interventions under investigation include: retifanlimab (DRUG).
Who is sponsoring clinical trial NCT03059823?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03059823's enrollment target sits among peer trials
325 111th of 2000 higher than 1,890 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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