INCB160058 for Myeloproliferative Disorder

Recruiting at 33 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must be taking: JAK inhibitors

Must not be taking: G-CSF, GM-CSF

Disqualifiers: Hematological malignancy, Major bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

186 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called INCB160058 to assess its safety and behavior in the body for individuals with certain blood disorders known as myeloproliferative neoplasms. The trial consists of two parts: the first part determines the appropriate dose, and the second part tests that dose in a larger group. Individuals with myelofibrosis (MF), polycythemia vera (PV), or essential thrombocythemia (ET) who have not responded well to previous treatments may be suitable candidates. Participants should be willing to undergo bone marrow tests and have a documented JAK2V617F mutation. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you stop any prior MF-directed therapy at least 28 days before starting the study treatment. Additionally, you must not be on certain treatments like G-CSF, GM-CSF, romiplostim, or eltrombopag within 4 weeks before the first dose.

Is there any evidence suggesting that INCB160058 is likely to be safe for humans?

Research shows that INCB160058 is being tested for safety and tolerance in people with myeloproliferative neoplasms, a group of blood disorders. Specific data from earlier studies on the safety of INCB160058 is not yet available. This trial is in its first phase, focusing primarily on determining the treatment's safety for humans. This phase typically involves a small number of participants to closely monitor any side effects or issues.

At this stage, researchers test treatments carefully to find the safest dose for future research. Because this is an early trial, safety information is still being gathered. Participants in this study will help researchers understand how people respond to the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for myeloproliferative disorder?

Unlike the standard treatments for myeloproliferative disorders, which often include drugs like hydroxyurea or ruxolitinib, INCB160058 is unique because it aims to identify a new dosing regimen that targets the maximum tolerated dose and optimal expansion dose. Researchers are excited about INCB160058 because it offers a novel approach to managing conditions like myelofibrosis, polycythemia vera, and essential thrombocythemia. By potentially offering a different mechanism of action, INCB160058 might address unmet needs in patients who do not fully benefit from existing therapies.

What evidence suggests that INCB160058 could be an effective treatment for myeloproliferative neoplasms?

Research has shown that the drug INCB160058, which participants in this trial may receive, may help treat certain blood disorders called myeloproliferative neoplasms, especially in individuals with a specific genetic change known as the JAK2 V617F mutation. Early lab studies demonstrated that this drug can target this mutation, often linked to diseases like myelofibrosis, polycythemia vera, and essential thrombocythemia. By focusing on this mutation, INCB160058 aims to slow down or stop disease progression. Initial results from studies suggest it might benefit patients who haven't responded to other treatments. ^{1 2 4 6 7}

Who Is on the Research Team?

Incyte Medical

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Myeloproliferative Neoplasms who've lived more than 6 months after diagnosis. They should have symptoms or an enlarged spleen and be at intermediate-1 risk or higher. Participants must have tried a JAK inhibitor treatment for at least 12 weeks without success, and be willing to undergo bone marrow tests.

Inclusion Criteria

I have been treated with a JAK inhibitor for 12 weeks or more and it didn't work for me.

My tests show a JAK2V617F mutation.

My condition is a type of bone marrow cancer that is at an intermediate-1 or higher risk level.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

INCB160058 is administered to identify the maximum tolerated dose and/or recommended dose for expansion in participants with myelofibrosis

4 weeks

Dose Expansion

INCB160058 is administered at the recommended dose identified during dose escalation to participants with myelofibrosis

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years and 30 days

What Are the Treatments Tested in This Trial?

Interventions

• INCB160058

Trial Overview The study is testing the safety, how well people can handle, and how the body processes INCB160058 in those with Myeloproliferative Neoplasms. It's specifically for patients who haven't responded well to previous treatments.

How Is the Trial Designed?

Group I: Part 2 Dose Expansion - with MF, PV or ET Experimental Treatment 1 Intervention

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

Group II: Part 2 Dose Expansion - with MF SubOpt R Experimental Treatment 2 Interventions

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.

Group III: Part 1 Dose Escalation - with MF, PV or ET Experimental Treatment 1 Intervention

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.

Group IV: Part 1 Dose Escalation - with MF SubOpt R Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

1. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-announces-more-50-abstracts-accepted-presentation-2025-0

Incyte Announces More than 50 Abstracts Accepted for ... The studies are evaluating the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) and/or recommended dose(s) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06313593

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

3. library.ehaweb.org library.ehaweb.org/eha/2025/eha2025-congress/4162195/jason.gotlib.a.multicenter.open-label.phase.1.study.of.incb160058.a.html?f=listing%3D3%2Abrowseby%3D8%2Asortby%3D1%2Amedia%3D1

A MULTICENTER, OPEN-LABEL PHASE 1 STUDY OF ... The INCB160058-101 phase 1 study is exploring the potential of INCB160058, a first-in-class JAK2 V617F mutant-specific inhibitor, in pts with MF ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123054642

Preclinical Evaluation of INCB160058 - a Novel and ... Preclinical Evaluation of INCB160058 - a Novel and Potentially Disease-Modifying Therapy for JAK2V617F Mutant Myeloproliferative Neoplasms.

5. ctsearchsupport.org ctsearchsupport.org/clinical-trials/a-study-to-evaluate-the-safety-tolerability-of-incb160058-in-participants-with-myeloproliferative-neoplasms

A drug, INCB160058, to treat myelofibrosis that has come ... A drug, INCB160058, to treat myelofibrosis that has come back (relapsed) or not gotten better with treatment (refractory)

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/472101

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

7. incytemi.com incytemi.com/pipeline/resource/NCT06313593?utm_source=linkedin&utm_medium=paidsocial&utm_campaign=hemonc&utm_id=paidsocialy5g1

patients with MF, PV, or ET 1. ClinicalTrials.gov. Accessed May 2025. https://clinicaltrials.gov/study/NCT06313593. 2. Data on file. Incyte Corporation.