A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
NCT ID: NCT06034002
Last Updated: 2025-10-30
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
230 participants
INTERVENTIONAL
2023-12-04
2028-10-29
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 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 to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants 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 or ET as defined in the protocol.
Exclusion Criteria
* Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
* Participants with laboratory values exceeding the protocol defined thresholds.
* Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
* Active invasive malignancy over the previous 2 years.
* History of clinically significant or uncontrolled cardiac disease.
* Active HBV/HCV or known history of HIV.
* 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, with the exception of ruxolitinib for TGBs only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
* 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.
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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City of Hope Medical Center
Duarte, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
University of Miami Health System
Miami, Florida, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Icahn School of Medicine At Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Md Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Related Links
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A study to Evaluate INCA033989 Administered in Participants with Myeloproliferative Neoplasms
Other Identifiers
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INCA33989-102
Identifier Type: -
Identifier Source: org_study_id
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