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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 is a Phase 1 study that has completed, run by Incyte Corporation. The registered enrollment target is 325 participants.
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.
Interventions
- DRUG retifanlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2016-11-15 |
| Est. Completion | 2024-05-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03059823
The ClinicalTrials.gov registry entry for NCT03059823 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 325 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 239 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which retifanlimab is the first listed.
NCT03059823 reports 0 study locations.
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.
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