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A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT05936359•Incyte Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Life expectancy \> 6 months.
•Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
•Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
•Participants with MF and ET as defined in the protocol.

Exclusion Criteria

•Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
•Active invasive malignancy over the previous 2 years.
•Active HBV/HCV, HIV.
•History of clinically significant or uncontrolled cardiac disease.
•Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
•Laboratory values outside the Protocol-defined ranges.
•Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.
•Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
•Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
•For TGBs only: Undergoing treatment with a potent/strong inhibitor or inducer of CYP 3A4/5 within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment, or expected to receive such treatment during the study.

Locations (29)

Royal Brisbane and Women'S Hospital

Herston, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Hopital Maisonneuve-Rosemont, Montreal, Qc

Montreal, Quebec, Canada

Odense University Hospital

Odense C, Denmark

Sjaellands Universitetshospital

Roskilde, Denmark

Vejle Hospital

Vejle, Denmark

Institut Bergonie

Bordeaux, France

Key Dates

Start Date

September 25, 2023

Primary Completion Date

February 29, 2028

Completion Date

February 29, 2028

Last Updated

February 10, 2026

Enrollment

225

ESTIMATED participants

Conditions

Myeloproliferative Neoplasms

Interventions

INCA033989

DRUG

Ruxolitinib

DRUG

Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463 medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423 eumedinfo@incyte.com

A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm

NCT06597734

Chronic Myelomonocytic LeukemiaAdvanced Myeloproliferative Neoplasms+1 more

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm

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