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RecruitingLast updated: 22 January 2024

This Phase II trial is evaluating how safe and effective a new drug (KER-050) is alone, and in combination with targeted therapy (ruxolitinib) in people with myelofibrosisA Phase 2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KER-050 as Monotherapy or in Combination With Ruxolitinib in Participants With Myelofibrosis

Clinical summary

Summary

This is a non-randomised, open-label trial with four experimental arms. In experimental arm 1a (dose escalation), participants will receive KER-050 monotherapy, administered via subcutaneous injection (SC) every 4 weeks, for up to 13 cycles. In experimental arm 1b (dose escalation), participants will receive KER-050, administered SC, every 4 weeks, for up to 13 cycles, in combination with standard of care ruxolitinib, administered orally twice daily. In experimental arm 2a (dose expansion), participants will receive KER-050 monotherapy, administered SC, every 4 weeks, for up to 13 cycles. In experimental arm 2b, participants will receive KER-050, administered SC every 4 weeks for up to 13 cycles, in combination with standard of care ruxolitinib, administered orally twice daily.

Conditions

This trial is treating patients with myelofibrosis

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

More information

Trial Identifiers

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Trial sponsor

Keros Therapeutics

Scientific Title

A Phase 2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KER-050 as Monotherapy or in Combination With Ruxolitinib in Participants With Myelofibrosis

Eligibility

Inclusion

  • Male or female ≥18 years of age, at the time of signing informed consent.
  • Diagnosis of PMF, post-PV MF, or post-ET MF according to the 2017 World Health Organization criteria.

Arm-specific criteria:

Arm 1A:

  • Previously treated with JAK inhibitor(s) or Participant is ineligible for JAK inhibitor(s)
  • Anemia, defined as hemoglobin ≤10 g/dL during screening, or receiving RBC transfusions

Arm 2A:

  • Previously treated with JAK inhibitor(s) or Participant is ineligible for JAK inhibitor(s)
  • Anemia, defined as hemoglobin ≤10 g/dL during screening, or receiving RBC transfusions

Arm-specific criteria for 1B and 2B:

  • Has been receiving ruxolitinib for ≥8 weeks prior to C1D1 and on a stable dose for ≥4 weeks prior to C1D1.
  • Anemia, defined as hemoglobin ≤10 g/dL during screening, or receiving RBC transfusions

Exclusion

  • Presence of the following cardiac conditions:

    1. New York Heart Association Class 3 or 4 heart failure
    2. QTcF >500 msec on the screening or C1D1 electrocardiogram (ECG)
    3. Uncontrolled clinically significant arrhythmia (participants with rate-controlled atrial fibrillation are not excluded)
    4. Acute myocardial infarction or unstable angina pectoris <6 months prior to C1D1
  • History of stroke, deep venous thrombosis, or arterial embolism within 6 months prior to C1D1.
  • Any malignancy other than PMF, post-ET MF, or post-PV MF that has not been in remission and/or has required systemic therapy including radiation, chemotherapy, hormonal therapy, or surgery, within 1 year prior to C1D1. In-situ cancers, squamous cell, and basal cell carcinomas which have been fully excised, and monoclonal gammopathy of unclear significance are allowed at the discretion of the Investigator.
  • History of solid organ or hematological transplantation.
  • Presence of uncontrolled hypertension, defined as systolic blood pressure ≥150 mm Hg or diastolic blood pressure ≥100 mm Hg despite adequate treatment.
  • Diagnosis of hemolytic anemia, active bleeding, hemoglobinopathies, or congenital disorders as a cause of the participant's anemia.
  • CTCAE Grade ≥2 bleeding events within the 3 months prior to C1D1.
  • Bone marrow blast percentage >2%. Participants with blast % between 2-5% are allowed if at least 2 bone marrows >6 months apart demonstrate stability of blast percentage, these participants must be reviewed with the Medical Monitor prior to study entry.
  • Prior treatment with luspatercept, sotatercept, or other commercially available or investigational TGF-β inhibitors (all Arms)
  • Treatment within 28 days prior to C1D1 with:

    1. Erythropoiesis stimulating agent (ESA)
    2. Granulocyte colony-stimulating factor (G-CSF)
    3. Granulocyte-macrophage colony-stimulating factor (GM-CSF)
    4. Thrombopoietin agonists (TPO)
    5. Immunomodulator imide drugs (IMiDs; e.g., thalidomide, pomalidomide, lenalidomide)
    6. Interferon

Inclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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