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

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Keros Therapeutics

Criteria

Key Inclusion Criteria:

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:

• 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

• 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.

Key Exclusion Criteria:

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:

1. Erythropoiesis stimulating agent (ESA) OR

2. Granulocyte colony-stimulating factor (G-CSF) OR

3. 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.