A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms
NCT ID: NCT06313593
Last Updated: 2025-11-10
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
186 participants
INTERVENTIONAL
2024-08-08
2028-10-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 Dose Escalation - with MF SubOpt R
INCB160058 will be administered at a protocol defined starting regimen and will allow for the evaluation of INCB160058 in combination with a standard disease-directed therapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF), suboptimal response to a standard disease-directed therapy (SubOpt R) will enroll in this group.
INCB160058
Oral; Tablet
Standard disease-directed therapy
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.
Part 2 Dose Expansion - with MF, PV or ET
INCB160058 will be administered at the RDE(s) identified during Part 1. Participants with MF, PV or ET will enroll in this group.
INCB160058
Oral; Tablet
Part 2 Dose Expansion - with MF SubOpt R
INCB160058 will be administered as an add-on therapy in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1. Participants with myelofibrosis (MF), suboptimal response to a standard disease-directed therapy (SubOpt R) will enroll in this group.
INCB160058
Oral; Tablet
Standard disease-directed therapy
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.
Part 1 Dose Escalation - with MF, PV or ET
INCB160058 will be administered at a protocol defined starting regimen to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF), polycythemia vera (PV) or essential thrombocythemia (ET) will enroll in this group.
INCB160058
Oral; Tablet
Interventions
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INCB160058
Oral; Tablet
Standard disease-directed therapy
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.
Eligibility Criteria
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Inclusion Criteria
* MF:
* Intermediate-1 or higher risk PMF, post-PV MF, or post-ET MF with evidence of minimum burden of disease based on splenomegaly, and for the monotherapy cohort, participants must have been previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.
* For the MF SubOpt R cohort: Therapeutic regimen prior to enrollment as defined in the protocol and unlikely to benefit from further monotherapy in the opinion of the investigator.
* PV: Confirmed diagnosis of PV and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.
* ET: Confirmed diagnosis of high-risk ET as defined in the protocol and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.
* Life expectancy \> 6 months.
* Willingness to undergo a pretreatment and regular on-study bone marrow biopsies and aspirations (as appropriate to disease).
* Existing documentation of JAK2V617F mutation from a qualified local laboratory.
Exclusion Criteria
* Prior history of major bleeding or thrombosis within the 3 months prior to study enrollment.
* Participants with abnormal hematologic, hepatic, or renal function based on laboratory evaluation.
* Has undergone prior allogenic or autologous stem-cell transplantation or allogenic stem-cell transplantation is planned
* Active invasive malignancy.
* Significant concurrent, uncontrolled medical condition.
* Acute or chronic HBV, active HCV or known HIV.
* Any prior MPN-directed therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
* Participants undergoing treatment with G-CSF or GM-CSF, romiplostim, or eltrombopag 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
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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The University of Alabama At Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center
Fairway, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Icahn School of Medicine At Mount Sinai
New York, New York, United States
Cornell Medical Center
New York, New York, United States
Sloan Kettering Institute For Cancer Research
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Md Anderson Cancer Center
Houston, Texas, United States
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont, Montreal, Qc
Montreal, Quebec, Canada
McGill University Jewish General Hospital
Montreal, Quebec, Canada
Hospital Saint Louis
Paris, , France
Institut Gustave Roussy
Villejuif, , France
University Medical Center Rwth Aachen
Aachen, , Germany
Universitatsklinikum Essen
Essen, , Germany
Universitatsklinikum Halle (Saale)
Halle, , Germany
Aou Policlinico S. Orsola-Malpighi
Bologna, , Italy
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Florence, , Italy
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, , Italy
Haukeland University Hospital
Bergen, , Norway
Oslo University Hospital
Oslo, , Norway
Inselspital - Universitaetsspital Bern
Bern, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Guys and St Thomas Nhs Foundation Trust
London, , United Kingdom
Genesiscare 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 the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms
Other Identifiers
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2024-520353-21-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB160058-101
Identifier Type: -
Identifier Source: org_study_id