A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

Keros Therapeutics, Inc.0 个研究点目标入组 104 人开始时间: 2021年11月17日最近更新: 2022年3月21日

试验速览

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•1. 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.
•2. < 5% blasts in bone marrow.
•3. Peripheral blood white blood cell (WBC) count < 13,000/µL.
•4. Anemia defined as:
•a. In LTB participants (defined as having received < 4 units of RBCs within 8 weeks), mean hemoglobin concentration < 10.0 g/dL of two measurements (one performed within 1 day prior to Cycle 1 Day 1 and the other performed 7-28 days prior, not influenced by RBC transfusion within 7 days of measurement) OR
•b. In HTB participants (defined as requiring > or = 4 units of RBCs for hemoglobin < or = 9.0 g/dL within 8 weeks)
•5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia.
•6. Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 34
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•1. 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.
•2. Diagnosis of secondary MDS (ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
•3. Vitamin B12 deficiency.
•4. Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.
•5. Treatment within 28 days prior to Cycle 1 Day 1 with:
•a. Erythropoiesis stimulating agent (ESA) OR
•b. Granulocyte colony-stimulating factor (G-CSF) OR
•c. Granulocyte-macrophage colony-stimulating factor (GM-CSF)
•6. Iron chelation therapy if initiated within 8 weeks prior to Cycle 1 Day 1.
•7. Vitamin B12 therapy within 8 weeks prior to Cycle 1 Day 1.
•8. 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.
•9. Platelet count > 450 x 10*9/L or < 30 x 10*9/L.
•10. Transferrin saturation < 15%.
•11. Ferritin < 50 µg/L.
•12. Folate < 4.5 nmol/L (< 2.0 ng/mL).
•13. Vitamin B12 < 148 pmol/L (< 200 pg/mL).
•14. Estimated glomerular filtration rate (GFR) < 40 mL/min/1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI].
•15. Pregnant or lactating females.

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