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Clinical Trials in the UK / NCT05936359
Active, not recruiting Phase 1

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

NCT05936359 · tracked via the Priya Life Science UK tracker
Sponsor
Incyte Corporation
Phase
Phase 1
Started
2023-09-25
Last updated
2026-08-10

Condition(s) studied

Myeloproliferative Neoplasms

Investigational drug(s) / intervention(s)

INCA033989Ruxolitinib

INCA033989: INCA033989 will be administered at protocol defined dose.

Ruxolitinib: Rux will be administered according to Prescribing Information/SmPC.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
Royal Brisbane and Women'S Hospital Herston Queensland
Royal Adelaide Hospital Adelaide South Australia
Peter Maccallum Cancer Centre Melbourne Victoria
The Alfred Hospital Melbourne Victoria
Princess Margaret Cancer Center Toronto Ontario
Hopital Maisonneuve-Rosemont, Montreal, Qc Montreal Quebec
Sjaellands Universitetshospital Roskilde Denmark
Vejle Hospital Vejle Denmark
Institut Bergonie Bordeaux France
Chu Nimes Nîmes France
Hospital Saint Louis Paris France
Institut Gustave Roussy Villejuif France
University Medical Center Rwth Aachen Aachen Germany
Universitatsklinikum Halle (Saale) Halle Germany
Universitätsklinikum Ulm Ulm Germany
Aou Policlinico S. Orsola-Malpighi Bologna Italy
Azienda Ospedaliero-Universitaria Careggi (Aouc) Florence Italy
Fondazione Irccs Ca Granda Ospedale Maggiore Milan Italy
National Cancer Center Hospital East Chiba-ken Japan
Kagoshima University Hospital Kagoshima Japan
Osaka Metropolitan University Hospital Osaka Japan
Nippon Medical School Hospital Tokyo Japan
Mie University Hospital Tsu Japan
Hospital Universitario 12 de Octubre Madrid Spain
Hospital Universitari I Politecnic La Fe Valencia Spain
Guys and St Thomas Nhs Foundation Trust London United Kingdom
The Christie Nhs Foundation Trust Uk Manchester United Kingdom
University of Oxford Oxford United Kingdom

On this site

📄 Jakafi (ruxolitinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05936359 on ClinicalTrials.gov ↗ ← All trials in the UK