Myelodysplastic Syndrome Clinical Trial

A Study of KER-050 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

Summary

The purpose of this study is to evaluate the effects of KER-050 on anemia in patients with very low, low or intermediate risk MDS.

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Full Description

KER-050 is a 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).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Diagnosis of MDS according to World Health Organization (WHO)/French American British (FAB) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease.
< 5% blasts in bone marrow.
Peripheral blood white blood cell (WBC) count < 13,000/µL.

Anemia defined as:

In non-transfused participants, having received no red blood cell (RBC) transfusions within 8 weeks Hgb concentration ≤ 10.0 g/dL OR
In LTB participants, having received 1 to 3 units RBCs for Hgb ≤ 9.0 g/dL within 8 weeks OR
In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia.
Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.

Key Exclusion Criteria:

Any active infection requiring parenteral antibiotic therapy within 28 days prior to Cycle 1 Day 1 or oral antibiotics within 14 days of Cycle 1 Day 1.
Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
Vitamin B12 deficiency.
Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.

Treatment within 28 days prior to Cycle 1 Day 1 with:

Erythropoiesis stimulating agent (ESA) OR
Granulocyte colony-stimulating factor (G-CSF) OR
Granulocyte-macrophage colony-stimulating factor (GM-CSF)
Iron chelation therapy if initiated within 8 weeks prior to Cycle 1 Day 1.
Vitamin B12 therapy within 8 weeks prior to Cycle 1 Day 1.
Treatment with another investigational drug or device or approved therapy for investigational use < or = 28 days prior to Cycle 1 Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Cycle 1 Day 1, whichever is longer.
Platelet count > 450 x 10*9/L or < 30 x 10*9/L.
Transferrin saturation < 15%.
Ferritin < 50 µg/L.
Folate < 4.5 nmol/L (< 2.0 ng/mL).
Vitamin B12 < 148 pmol/L (< 200 pg/mL).
Estimated glomerular filtration rate (GFR) < 40 mL/min/1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI].
Pregnant or lactating females.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

110

Study ID:

NCT04419649

Recruitment Status:

Recruiting

Sponsor:

Keros Therapeutics, Inc.

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There are 16 Locations for this study

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University of Miami, Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States More Info
Mikkael A Sekeres, MD
Contact
Mikkael A Sekeres, MD
Principal Investigator
Border Medical Oncology Research Unit
Albury New South Wales, 2640, Australia More Info
Anish Puliyayil
Contact
The Tweed Hospital
Tweed Heads New South Wales, 2485, Australia More Info
Alejandro Arbelaez
Contact
Westmead Hospital
Westmead New South Wales, 2145, Australia More Info
John Kwan
Contact
Townsville University Hospital
Douglas Queensland, 4814, Australia More Info
Joel Wight
Contact
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia More Info
Devendra Hiwase
Contact
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia More Info
David Ross
Contact
Box Hill Hospital
Box Hill Victoria, 3128, Australia More Info
Tse-Chieh Teh
Contact
University Hospital Geelong
Geelong Victoria, 3220, Australia More Info
Hannah Rose
Contact
Austin Health
Heidelberg Victoria, 3084, Australia More Info
Chun Fong
Contact
Royal Melbourne Hospital
Melbourne Victoria, 3050, Australia More Info
Lynette Chee
Contact
St Vincent's Hospital Melbourne
Melbourne Victoria, 3065, Australia More Info
Shuh Ying Tan
Contact
Ballarat Oncology and Haematology Service
Wendouree Victoria, 3355, Australia More Info
George Kannourakis
Contact
Klinikum Bayreuth GmbH
Bayreuth , , Germany More Info
Alexander Kiani
Contact
Klinikum Esslingen GmbH
Esslingen , , Germany More Info
Swen Wessendorf
Contact
Sheba Medical Center
Ramat Gan , 52621, Israel More Info
Drorit Merkel
Contact
Tel-Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel More Info
Yakir Moshe
Contact
Middlemore Hospital
Auckland , 2025, New Zealand More Info
James Liang
Contact
Hospital Universitario Central de Asturias
Barcelona , , Spain More Info
Teresa Bernal del Castillo
Contact
Hospital Universitario Vall d'Hebron
Barcelona , , Spain More Info
David V Ferreiras
Contact
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona , , Spain More Info
Montserrat Sangerman
Contact
Hospital Universitario de Salamanca
Salamanca , , Spain More Info
Maria Campelo
Contact
Hospital Universitario Virgen del Rocio
Sevilla , , Spain More Info
Jose Gonzalez
Contact
Hospital Universitari i Politecnic La Fe
Valencia , , Spain More Info
Guillermo Santillana
Contact

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

110

Study ID:

NCT04419649

Recruitment Status:

Recruiting

Sponsor:


Keros Therapeutics, Inc.

How clear is this clinincal trial information?

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