NCT05936359

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.

Conditions

• Myeloproliferative Neoplasms

Interventions

Type	Name	Description
DRUG	INCA033989	INCA033989 will be administered at protocol defined dose.
DRUG	Ruxolitinib	Rux will be administered according to Prescribing Information/SmPC.

Timeline

• Start date: 2023-09-25
• Primary completion: 2028-02-29
• Completion: 2028-02-29
• First posted: 2023-07-07
• Last updated: 2026-03-24

Locations

29 sites across 9 countries: Australia, Canada, Denmark, France, Germany, Italy, Japan, Spain, United Kingdom

Regulatory

• FDA-regulated drug study