OncoMatch/Clinical Trials/NCT04419649
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
Official 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)
Is NCT04419649 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies Elritercept for myelodysplastic syndromes.
Treatment: Elritercept — The main aim of this study is to learn how safe elritercept is and how well adults with anemia associated with lower-risk MDS tolerate treatment with different doses of elritercept. Other aims are to learn how safe elritercept is by looking at how many participants have MDS that worsens during the study and learn about the effects of elritercept on anemia linked to MDS. The study will also look to learn how elritercept affects the production of healthy RBCs.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Myelodysplastic Syndrome
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: azacitidine
Prior treatment with azacitidine
Cannot have received: decitabine
Prior treatment with decitabine
Cannot have received: lenalidomide
Prior treatment with lenalidomide
Cannot have received: luspatercept
Exception: Cohorts A, B, C, D, E, and F only
Prior treatment with luspatercept (Cohorts A, B, C, D, E, and F only)
Cannot have received: sotatercept
Prior treatment with sotatercept
Cannot have received: granulocyte colony-stimulating factor
Prior or concurrent chronic treatment with G-CSF
Cannot have received: granulocyte-macrophage colony-stimulating factor
Prior or concurrent chronic treatment with GM-CSF
Cannot have received: imetelstat
Exception: Cohort G only
Prior treatment with imetelstat (Cohort G only)
Lab requirements
Blood counts
Platelet count > 25 × 10^9/L and < 800 × 10^9/L (Part 2); > 30 × 10^9/L and < 450 × 10^9/L (Part 1)
Kidney function
Estimated GFR ≥ 30 mL/min/1.73 m^2 as determined by the CKD-EPI equation
Cardiac function
No uncontrolled heart disease or NYHA Class III/IV heart failure; QTcF ≤ 500 msec; no uncontrolled clinically significant arrhythmia; no acute MI or unstable angina ≤ 6 months prior to C1D1
Presence of uncontrolled heart disease or NYHA Class III or IV heart failure; QTcF > 500 msec; uncontrolled arrhythmia; acute MI or unstable angina ≤ 6 months prior to C1D1; Platelet count > 800 × 10^9/L or < 25 × 10^9/L; Estimated GFR < 30 mL/min/1.73 m^2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Genesis Cancer and Blood Institute · Hot Springs, Arkansas
- City of Hope National Medical Center · Duarte, California
- University of Miami School of Medicine Sylvester Comprehensive Cancer Center (SCCC) · Miami, Florida
- H. Lee Moffitt Cancer Center and Research Center · Tampa, Florida
- The Center for Cancer and Blood Disorders (CCBD) - Bethesda · Bethesda, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04419649 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior azacitidine, decitabine, lenalidomide disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages