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)
Takeda
Summary
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.
Description
Elritercept (KER-050) is a recombinant fusion protein being studied to increase red blood cell production by inhibiting the signaling of a subset of the transforming growth factor beta (TGF-ß) family of proteins.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. Male or female ≥ 18 years of age, at the time of signing informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia). 4. Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception. 5. In the opinion of the Investigator,…
Interventions
- DrugElritercept
Elritercept SC injection.
Locations (47)
- City of Hope National Medical CenterDuarte, California
- University of Miami School of Medicine Sylvester Comprehensive Cancer Center (SCCC)Miami, Florida
- H. Lee Moffitt Cancer Center and Research CenterTampa, Florida
- Karmanos Cancer Institute at Mclaren Greater LansingLansing, Michigan
- University of Pittsburgh Medical Health CenterPittsburgh, Pennsylvania
- Border Medical Oncology ResearchAlbury, New South Wales