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Active, not recruiting Phase 1

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

NCT06313593 · tracked via the Priya Life Science France tracker
Phase
Phase 1
Started
2024-08-08
Last updated
2026-08-12

Condition(s) studied

Myeloproliferative Neoplasms

Investigational drug(s) / intervention(s)

INCB160058Standard disease-directed therapy

INCB160058: Oral; Tablet

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy 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.

Primary outcome measure(s)

  • Number of participants with Dose Limiting Toxicities (DLTs) — Up to 28 days
    Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
  • Number of participants with Treatment-emergent Adverse Events (TEAEs) — Up to 2 years and 30 days
    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
  • Number of participants with TEAEs leading to dose modification or discontinuation — Up to 2 years and 30 days
    Number of participants with TEAEs leading to dose modification or discontinuation.

Trial sites (30)

FacilityCityRegionStatus
The University of Alabama At Birmingham Birmingham Alabama
Stanford University Palo Alto California
Moffitt Cancer Center Tampa Florida
Northwestern University Chicago Illinois
The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center Fairway Kansas
University of Michigan Ann Arbor Michigan
Cornell Medical Center New York New York
Icahn School of Medicine At Mount Sinai New York New York
Sloan Kettering Institute For Cancer Research New York New York
Oregon Health & Science University Portland Oregon
University of Pennsylvania Health System Philadelphia Pennsylvania
Vanderbilt-Ingram Cancer Center Nashville Tennessee
Md Anderson Cancer Center Houston Texas
Princess Margaret Cancer Center Toronto Ontario
Hopital Maisonneuve-Rosemont, Montreal, Qc Montreal Quebec
McGill University Jewish General Hospital Montreal Quebec
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06313593 on ClinicalTrials.gov ↗ ← All trials in France