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RecruitingInterventionalPhase 1

A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms

NCT ID: NCT06313593Sponsor: Incyte CorporationLast updated: 2026-05-04

Summary

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

Arms & interventions

  • DrugINCB160058

    Oral; Tablet

  • DrugStandard disease-directed therapy

    A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.

Outcome measures

Primary

  • Number of participants with Dose Limiting Toxicities (DLTs)

    Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.

    Time frame: Up to 28 days

  • Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

    Time frame: Up to 2 years and 30 days

  • Number of participants with TEAEs leading to dose modification or discontinuation

    Number of participants with TEAEs leading to dose modification or discontinuation.

    Time frame: Up to 2 years and 30 days

Secondary

  • INCB160058 and a standard disease-directed therapy pharmacokinetic (PK) in Plasma

    Time frame: Up to Day 57

  • For participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF

    Time frame: Week 12 and 24 and then every 24 weeks up to 2 years

  • For participants with MF: Percentage of participants achieving spleen volume reduction as defined in the protocol

    Time frame: Week 12 and Week 24

  • For participants with PV: Response using revised IWG-MRT and ELN response criteria for PV

    Time frame: Week 12 and 24 and then every 24 weeks up to 2 years

  • For participants with ET: Response using revised IWG-MRT and ELN response criteria for ET

    Time frame: Week 12 and 24 and then every 24 weeks up to 2 years

  • For all participants: Percentage of participants achieving ≥ 50% reduction from baseline of total symptom score (TSS)

    Time frame: Week 24

  • For all participants: Symptom improvement in TSS at Weeks 12 and 24 relative to baseline as measured by the Myeloproliferative Neoplasms Symptom Assessment Form (MPN-SAF) TSS.

    Time frame: Week 12 and Week 24

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (13)

The University of Alabama At Birmingham

Birmingham, Alabama, 35249

Recruiting

Stanford University

Palo Alto, California, 94304

Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

Northwestern University

Chicago, Illinois, 60611

Recruiting

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

Fairway, Kansas, 66205

Recruiting

University of Michigan

Ann Arbor, Michigan, 48109-5008

Recruiting

Cornell Medical Center

New York, New York, 10021

Recruiting

Icahn School of Medicine At Mount Sinai

New York, New York, 10029

Recruiting

Sloan Kettering Institute For Cancer Research

New York, New York, 10065

Recruiting

Oregon Health & Science University

Portland, Oregon, 97239

Recruiting

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104

Recruiting

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232

Recruiting

Md Anderson Cancer Center

Houston, Texas, 77030

Recruiting