A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
NCT ID: NCT05936359
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
225 participants
INTERVENTIONAL
2023-09-25
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1a Dose Escalation Cohort Disease Group A - with MF
INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF) will enroll in this group.
INCA033989
INCA033989 will be administered at protocol defined dose.
Part 1a Dose Escalation Cohort Disease Group A - with ET
INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with with essential thrombocythemia (ET) will enroll in this group.
INCA033989
INCA033989 will be administered at protocol defined dose.
Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt R
INCA033989 will be administered at a protocol defined starting regimen in 28- day cycles and will allow for the evaluation of INCA033989 in combination with ruxolitinib to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF) exhibiting suboptimal response (SubOpt R) will enroll in this group.
INCA033989
INCA033989 will be administered at protocol defined dose.
Ruxolitinib
Rux will be administered according to Prescribing Information/SmPC.
Part 1b: Dose Expansion - with MF
INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group.
INCA033989
INCA033989 will be administered at protocol defined dose.
Part 1b: Dose Expansion - with TGB-MF SubOpt R
INCA033989 will be administered as an add-on therapy in combination with ruxolitinibat at the RDE(s) identified during Part 1a. Participants with treatment Group B (TGB) MF SubOpt R will enroll in this group.
INCA033989
INCA033989 will be administered at protocol defined dose.
Ruxolitinib
Rux will be administered according to Prescribing Information/SmPC.
Part 1b: Dose Expansion - with ET
INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group.
INCA033989
INCA033989 will be administered at protocol defined dose.
Part 1c: Dose Expansion
INCA033989 will be administered at the dose level found to exhibit an overall positive benefit/risk as monotherapy or as combination therapy with Ruxolitinib. Participants with myelofibrosis (MF) will enroll in this group. The participants enrolled in the monotherapy arm will be offered the option to crossover to combination therapy with ruxolitinib if a suboptimal response to monotherapy is observed after 12 weeks.
INCA033989
INCA033989 will be administered at protocol defined dose.
Ruxolitinib
Rux will be administered according to Prescribing Information/SmPC.
Interventions
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INCA033989
INCA033989 will be administered at protocol defined dose.
Ruxolitinib
Rux will be administered according to Prescribing Information/SmPC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
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, , 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
Countries
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Central Contacts
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Related Links
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A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
Other Identifiers
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2022-502514-86-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCA 33989-101
Identifier Type: -
Identifier Source: org_study_id
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