A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies
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Phase
Phase 1
Status
Terminated
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
83actual
Sites
18
Countries
Denmark, Netherlands, Norway +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
The study was terminated after careful review of the overall clinical activity of this compound and a lack of robust efficacy. The study closure is not based on safety concerns.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2018-08-27 | actual | When the study began enrolling |
| Primary completion | 2025-09-10 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-09-10 | actual | The whole study's end, after follow-up |
| First posted | 2018-05-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Solid Tumors
Interventions
- Drug: INCB081776
- Drug: INCMGA00012 — also filed as retifanlimab
Primary outcomes
what the primary-completion date above is the date OFPart 1 (1A and 1B): Number of treatment-emergent adverse events (TEAEs)
measured Screening through 90 days after end of treatment, up to approximately 1 year.
Part 1 (1A and 1B): Recommended Dose for Expansion (RDE)
measured Up to one year
Part 2 (2A & 2B): Number of treatment-emergent adverse events
measured Screening through 90 days after end of treatment, up to approximately 1 year
Part 2 (2A & B): RDE in combination with INCMGA00012
measured Up to one year
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