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

NCT06313593 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: INCB160058-1012024-520353-21-00
• Study Type: interventional
• Target: 186
• Locations: 8 countries
• Sites: 30

Brief Summary

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

Conditions

Myeloproliferative Neoplasms

Keywords

Myeloproliferative Neoplasms; INCB160058; Myelofibrosis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to 2 years and 30 days

Secondary Outcomes (7)

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

  Up to Day 57

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

  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

  Week 12 and Week 24

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

  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

  Week 12 and 24 and then every 24 weeks up to 2 years

Study Arms (4)

Part 1 Dose Escalation - with MF, PV or ET

EXPERIMENTAL

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.

Drug: INCB160058

Part 1 Dose Escalation - with MF SubOpt R

EXPERIMENTAL

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.

Drug: INCB160058; Drug: Standard disease-directed therapy

Part 2 Dose Expansion - with MF, PV or ET

EXPERIMENTAL

INCB160058 will be administered at the RDE(s) identified during Part 1. Participants with MF, PV or ET will enroll in this group.

Drug: INCB160058

Part 2 Dose Expansion - with MF SubOpt R

EXPERIMENTAL

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.

Drug: INCB160058; Drug: Standard disease-directed therapy

Interventions

INCB160058 DRUG

Oral; Tablet

Part 1 Dose Escalation - with MF SubOpt R; Part 1 Dose Escalation - with MF, PV or ET; Part 2 Dose Expansion - with MF SubOpt R; Part 2 Dose Expansion - with MF, PV or ET

Standard disease-directed therapy DRUG

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

Part 1 Dose Escalation - with MF SubOpt R; Part 2 Dose Expansion - with MF SubOpt R

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (30)

The University of Alabama At Birmingham

Birmingham, Alabama, 35249, United States

RECRUITING

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

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

Fairway, Kansas, 66205, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109-5008, United States

RECRUITING

Cornell Medical Center

New York, New York, 10021, United States

RECRUITING

Icahn School of Medicine At Mount Sinai

New York, New York, 10029, United States

RECRUITING

Sloan Kettering Institute For Cancer Research

New York, New York, 10065, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

Md Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Hopital Maisonneuve-Rosemont, Montreal, Qc

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

McGill University Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Hospital Saint Louis

Paris, 75010, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

University Medical Center Rwth Aachen

Aachen, D-52074, Germany

RECRUITING

Universitatsklinikum Essen

Essen, 45147, Germany

NOT YET RECRUITING

Universitatsklinikum Halle (Saale)

Halle, 06120, Germany

RECRUITING

Aou Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria Careggi (Aouc)

Florence, 50134, Italy

NOT YET RECRUITING

Fondazione Irccs Ca Granda Ospedale Maggiore

Milan, 20122, Italy

NOT YET RECRUITING

Haukeland University Hospital

Bergen, N-5021, Norway

RECRUITING

Oslo University Hospital

Oslo, 00379, Norway

RECRUITING

Inselspital - Universitaetsspital Bern

Bern, 03010, Switzerland

RECRUITING

Universitatsspital Zurich

Zurich, 08091, Switzerland

RECRUITING

Guys and St Thomas Nhs Foundation Trust

London, SE1 9RT, United Kingdom

NOT YET RECRUITING

Genesiscare Oxford

Oxford, OX4 6LB, United Kingdom

NOT YET RECRUITING

Related Links

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

MeSH Terms

Conditions

Myeloproliferative Disorders; Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Incyte Medical

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): October 9, 2028
• Study Completion (Estimated): October 9, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (13); DE (3); GB (2); NO (2); CH (2); IT (3); FR (2)