A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
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.
Eligibility criteria
Qualifiers
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local study participant privacy regulations.
Male or female ≥ 18 years of age, at the time of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia).
Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.
Disqualifiers
Diagnosis of MDS with deletion of chromosome 5q (Del5q).
Active infection requiring parenteral antibiotic therapy within 28 days prior to C1D1 or oral antibiotics within 14 days of C1D1. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.
Presence of uncontrolled heart disease or New York Heart Association (NYHA) Class III or IV heart failure.
History of drug or alcohol abuse (as defined by the Investigator) within the past 2 years.
Trial design
Treatments tested in this trial
- Elritercept
Treatment groups
160 Participants
are divided into 13 treatment groups13
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov