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

PHASE2RECRUITING

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.

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Study details:

KER-050 is an investigational therapeutic protein designed to increase red blood cell and platelet production by inhibiting the signaling of a subset of the transforming growth factor beta (TGF-ß) family of proteins to promote hematopoiesis. It is being developed for the treatment of low blood cell counts, or cytopenias including anemia and thrombocytopenia in patients with Myelodysplastic Syndrome (MDS) and Myelofibrosis (MF).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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 1A: Previously treated with JAK inhibitor(s) or Participant is ineligible for JAK inhibitor(s)

Arm 1A: 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)

Arm 2A: 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.

Arm-specific criteria for 1B and 2B: Anemia, defined as hemoglobin ≤10 g/dL during screening, or receiving RBC transfusions

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-12-16

Primary completion: 2025-04-01

Study completion finish: 2025-06-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05037760

Intervention or treatment

DRUG: KER-050 monotherapy

DRUG: KER-050 in combination with ruxolitinib

Conditions

• Myelofibrosis

Condition: Myelofibrosis
DRUG: KER-050 monotherapy and other drugs
Tweed Heads, New South Wales, Australia and more
Sponsor: Keros Therapeutics, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

The Tweed Hospital

Research sites nearby

Select from list below to view details:

The Tweed Hospital
Tweed Heads, New South Wales, Australia
Flinders Medical Centre
Woodville South, South Australia, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm 1a Dose Escalation KER-050 (SC, solution for injection, every 4 weeks) monotherapy	DRUG: KER-050 monotherapy KER-050 administered (SC) for up to 13 cycles
EXPERIMENTAL: Arm 1b Dose Escalation KER-050 (SC, solution for injection, every 4 weeks) in combination with standard of care ruxolitinib (oral, tablet, twice daily)	DRUG: KER-050 in combination with ruxolitinib KER-050 administered (SC) for up to 13 cycles in combination with standard of care ruxolitinib
EXPERIMENTAL: Arm 2a Dose Expansion KER-050 (SC, solution for injection, every 4 weeks) monotherapy	DRUG: KER-050 monotherapy KER-050 administered (SC) for up to 13 cycles
EXPERIMENTAL: Arm 2b Dose Expansion KER-050 (SC, solution for injection, every 4 weeks) in combination with standard of care ruxolitinib (oral, tablet, twice daily)	DRUG: KER-050 in combination with ruxolitinib KER-050 administered (SC) for up to 13 cycles in combination with standard of care ruxolitinib

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence of adverse events (Safety and Tolerability)	Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs)	64 Weeks

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Subgroup of transfusion-independent participants	* Proportion of participants with mean hemoglobin increase ≥1.5 g/dL from baseline over a period of \>12 consecutive weeks * Proportion of participants with mean hemoglobin increase ≥2.0 g/dL from baseline over a period of \>12 consecutive weeks * Proportion of participants with a decrease of ≥1 in Brief Fatigue Inventory (BFI) score from baseline	24 weeks
Subgroup of participants with anemia requiring red blood cell (RBC) transfusions	* Proportion of participants with RBC transfusion independence over a period of \>12 consecutive weeks * Proportion of participants with decrease in number of RBC transfusions from baseline over a period of \>12 consecutive weeks	24 weeks
Proportion of participants with decrease in spleen volume of ≥35% from baseline as measured by computed tomography (CT) (excluding participants status post splenectomy or splenic irradiation)	Not Specified	At Week 24 and at Week 52
Proportion of participants with improvement in the Myelofibrosis Symptom Assessment Form Total Symptom Score (MF-SAF-TSS) of ≥50% from baseline	Not Specified	At Week 24 and at Week 52
Proportion of participants with progression to AML (bone marrow blasts >20%)	Not Specified	At Week 24 and at Week 52
Proportion of participants with progression to accelerated MF (bone marrow blasts ≥10%)	Not Specified	At Week 24 and at Week 52

Frequently Asked Questions

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References

Clinical Trials Gov: Study to Evaluate KER-050 as a Monotherapy or in Combination With Ruxolitinib in Myelofibrosis