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NCT06313593PHASE1Recruiting

A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms

Incyte Corporation

Start Date

8/8/2024

Completion Date

10/9/2028

Summary

This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age ≥ 18 years * 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: * Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, post-ET MF, PV, or ET. * 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. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Interventions

DRUG

INCB160058

DRUG

Standard disease-directed therapy

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Conditions

Myeloproliferative Neoplasms

Locations

The University of Alabama At Birmingham

Birmingham, Alabama 35249

United States

Stanford University

Palo Alto, California 94304

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Northwestern University

Chicago, Illinois 60611

United States

The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center

Fairway, Kansas 66205

United States

University of Michigan

Ann Arbor, Michigan 48109-5008

United States

Cornell Medical Center

New York, New York 10021

United States

Icahn School of Medicine At Mount Sinai

New York, New York 10029

United States

Sloan Kettering Institute For Cancer Research

New York, New York 10065

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

University of Pennsylvania Health System

Philadelphia, Pennsylvania 19104

United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee 37232

United States

Md Anderson Cancer Center

Houston, Texas 77030

United States

Princess Margaret Cancer Center

Toronto, Ontario M5G 2M9

Canada

Hopital Maisonneuve-Rosemont, Montreal, Qc

Montreal, Quebec H1T 2M4

Canada

McGill University Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

Hospital Saint Louis

Paris, 75010

France

Institut Gustave Roussy

Villejuif, 94805

France

University Medical Center Rwth Aachen

Aachen, D-52074

Germany

Universitatsklinikum Essen

Essen, 45147

Germany

Universitatsklinikum Halle (Saale)

Halle, 06120

Germany

Aou Policlinico S. Orsola-Malpighi

Bologna, 40138

Italy

Azienda Ospedaliero-Universitaria Careggi (Aouc)

Florence, 50134

Italy

Fondazione Irccs Ca Granda Ospedale Maggiore

Milan, 20122

Italy

Haukeland University Hospital

Bergen, N-5021

Norway

Oslo University Hospital

Oslo, 00379

Norway

Inselspital - Universitaetsspital Bern

Bern, 03010

Switzerland

Universitatsspital Zurich

Zurich, 08091

Switzerland

Guys and St Thomas Nhs Foundation Trust

London, SE1 9RT

United Kingdom

Genesiscare Oxford

Oxford, OX4 6LB

United Kingdom