Study to Evaluate KER-050 as a Monotherapy or in Combination With Ruxolitinib in Myelofibrosis

• Status: Not yet recruiting
• Trial end date: 2024-11-23
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, multicenter, open-label study to evaluate the safety and efficacy of KER-050 as monotherapy or in combination with ruxolitinib in participants with Myelofibrosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keros Therapeutics
• Collaborator: IQVIA Biotech

Criteria

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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