InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated: 3 April 2024

This phase II trial is evaluating the effects of a new drug on anemia, in patients who have very low, low or intermediate risk Myelodysplastic Syndromes (MDS)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)

Clinical summary

Summary

Eligible participants will be assigned to receive either escalating or a confirmed dose of KER-050, subcutaneously, every 4 weeks for up to 4 cycles.

Conditions

This trial is treating patients with very low, low, or intermediate risk Myelodysplastic Syndromes (MDS)

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Keros Therapeutics

Scientific Title

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)

Eligibility

Inclusion

  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 count <13,000/µL.
  4. Anemia defined as:

    1. In non-transfused participants, having received no red blood cell (RBC) transfusions within 8 weeks Hgb concentration ≤ 10.0 g/dL OR
    2. In LTB participants, having received 1 to 3 units RBCs for Hgb ≤ 9.0 g/dL within 8 weeks OR
    3. In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 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.

Exclusion

  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 (i.e., MDS 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

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.