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Study of TP-3654 and Momelotinib for Patients with Intermediate or High-risk Myelofibrosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called myelofibrosis, which is a type of blood cancer that affects the bone marrow. The study is investigating the effects of a new treatment called TP-3654, which is taken as a capsule. Additionally, the study is exploring the combination of TP-3654 with another medication called momelotinib, which is taken as a tablet. The purpose of the study is to determine the safety and effectiveness of these treatments in patients with intermediate or high-risk primary or secondary myelofibrosis.

Participants in the study will receive either TP-3654 alone or in combination with momelotinib. The study will be conducted in two phases. In the first phase, researchers will determine the appropriate dose of TP-3654, both as a standalone treatment and in combination with momelotinib. In the second phase, the study will assess the preliminary effects of these treatments on the disease. Throughout the study, participants will be monitored for any side effects and changes in their condition.

The study aims to provide valuable information on how these treatments can help manage myelofibrosis. Participants will take the medications orally and will be regularly assessed to track their response to the treatment. The study will also evaluate changes in symptoms and overall health status to understand the potential benefits of TP-3654 and its combination with momelotinib for patients with myelofibrosis.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be assigned to one of the study arms. The study involves two main arms: TP-3654 Monotherapy and TP-3654 + Momelotinib Combination.

    The patient will be required to provide informed consent, confirming understanding and agreement to comply with the study requirements.

  2. Step 2

    Phase 1: Dose Escalation

    In this phase, the patient will receive TP-3654 orally. The form of the medication may be a capsule or tablet.

    The goal is to identify the recommended dose for Phase 2 by gradually increasing the dose while monitoring for any side effects.

  3. Step 3

    Phase 1: Safety Assessment

    The patient's health will be closely monitored to assess the safety of TP-3654 or the combination of TP-3654 + Momelotinib.

    This includes regular check-ups and tests to observe any adverse effects.

  4. Step 4

    Phase 2: Clinical Activity Assessment

    The patient will continue to receive the medication at the recommended dose identified in Phase 1.

    The focus will be on evaluating the effectiveness of the treatment in reducing symptoms and improving health outcomes.

  5. Step 5

    Medication Administration

    The patient will take TP-3654 orally, either as a capsule or tablet, as prescribed by the study protocol.

    If assigned to the combination arm, the patient will also take Momelotinib orally.

  6. Step 6

    Regular Monitoring

    Throughout the study, the patient will undergo regular monitoring, including blood tests and imaging, to track the response to the treatment.

    The patient's symptoms and overall health will be evaluated periodically to ensure safety and effectiveness.

  7. Step 7

    Completion of Study Participation

    Upon completion of the study, the patient will have a final evaluation to assess the overall impact of the treatment.

    The study is estimated to conclude by April 2030, with individual participation duration varying based on the study arm and response to treatment.

Who can join the trial?

17 criteria

  • Must be an adult, which means 18 years of age or older.
  • Must have a confirmed diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera (PV)-MF/post-essential thrombocythemia (ET)-MF, which are specific types of blood disorders.
  • Must have intermediate or high-risk primary or secondary myelofibrosis, as determined by a specific scoring system called the Dynamic International Prognostic Scoring System (DIPSS).
  • Must have been previously treated with a JAK inhibitor, which is a type of medication, and either did not tolerate it, it did not work, or they are not eligible for it.
  • Must have a condition called splenomegaly, which means the spleen is enlarged, measured as at least 5 cm below the rib cage or a certain volume by imaging tests.
  • Must be able to swallow medication that is taken by mouth.
  • Must have a life expectancy of at least 6 months.
  • Must have a performance status of 1 or less, which means they are fully active or have some symptoms but can still do light work.
  • Must have adequate kidney function, shown by specific blood test results.
  • Must have adequate liver function, shown by specific blood test results.
  • Must have adequate blood clotting function, shown by specific blood test results.
  • Must be able to provide signed informed consent, which means they understand the study and agree to participate.
  • Must be non-fertile or agree to use a reliable method of birth control.
  • Must have at least two symptoms related to their condition that can be measured and scored.
  • For Arm 3, must have been previously treated with a JAK inhibitor (except momelotinib) for at least 12 weeks, or at least 4 weeks if there were complications like needing blood transfusions or severe side effects.
  • For Arm 3, must have anemia, which means low levels of hemoglobin in the blood, and meet other specific blood test criteria.
  • For Arm 3, must have at least two symptoms with a certain severity score or a total average score based on a specific assessment tool.

Who cannot join the trial?

5 criteria

  • Patients who have a different medical condition than the one being studied, which is **Intermediate or High-risk Primary or Secondary Myelofibrosis**.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the clinical trial group being studied.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • TP-3654

    is an investigational medication being studied for its potential use in treating patients with intermediate or high-risk primary or secondary myelofibrosis. The study aims to determine the appropriate dosage for future phases and to evaluate the safety and initial effectiveness of this medication when used alone.

  • Momelotinib

    is a medication that is being tested in combination with TP-3654. The goal is to find the right dosage for the combination and to assess the safety and preliminary effectiveness of using both medications together in treating myelofibrosis.

What is already known about the treatment

  • TP-3654

    This medication is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating intermediate or high-risk primary or secondary myelofibrosis. It is in the early stages of research, with ongoing studies to determine the appropriate dosage and assess its preliminary clinical activity. TP-3654 is being investigated as a monotherapy and in combination with another drug, momelotinib. It works by targeting specific pathways involved in the disease process, although the exact molecular mechanism is still under investigation. TP-3654 is classified as an investigational drug, meaning it is not yet approved for general medical use.

  • Momelotinib

    This medication is also administered orally and is being studied in combination with TP-3654 for the treatment of intermediate or high-risk primary or secondary myelofibrosis. Momelotinib is further along in its development, with some existing data on its safety and effectiveness. It primarily works by inhibiting certain enzymes that contribute to the disease's progression, helping to manage symptoms and potentially slow the disease. Momelotinib is classified as a Janus kinase (JAK) inhibitor, a type of medication that targets specific signaling pathways in cells.

Investigated diseases

Myelofibrosis – Myelofibrosis is a rare bone marrow disorder characterized by the replacement of bone marrow with fibrous tissue, leading to a decrease in the production of blood cells. This condition can be primary, occurring on its own, or secondary, developing as a result of another bone marrow disorder. As the disease progresses, patients may experience symptoms such as fatigue, weakness, and an enlarged spleen. The reduction in blood cell production can lead to anemia, increased risk of infections, and bleeding issues. Over time, myelofibrosis can cause significant discomfort and impact daily life due to its chronic nature.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502597-16-00Protocol codeBBI-TP-3654-102Estimated enrolment245 patientsSponsorSumitomo Pharma America Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).