A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

Recruiting now · Phase 2

Conditions studied: Myelodysplastic Syndromes, Cytopenia

In brief

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.

Key facts

Study ID

NCT04419649

Run by

Takeda

People needed

160

Starts

2020-08-19

Expected to finish

2031-10-30

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).
• Part 1 Inclusion Criteria
• Participants are eligible to be included in Part 1 of the study only if all the following criteria apply:
• Diagnosis of MDS according to WHO classification that meets International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.
• Less than (<)5percent (%) blasts in bone marrow during the Pretreatment Period.
• Peripheral blood white blood cell (WBC) count <13,000/microliter (μL) during the Pretreatment Period.
• Anemia defined as:
• In non-transfused participants, having received no RBC transfusions within 8 weeks, Hgb concentration ≤ 10.0 g/dL during the Pretreatment Period OR
• In LTB participants, having received 1 to 3 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks of the Pretreatment Period.
• OR
• In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks of the Pretreatment Period.
• Part 1 Extension - Abbreviated Inclusion Criteria
• Participants from Part 1 are eligible to be included in Part 1 Extension of the study only if all the following criteria apply:
• Previously completed 4 cycles of elritercept in Part 1 with no dose-limiting toxicities (DLTs).
• Participant has the potential to benefit from administration of elritercept, in the opinion of the Investigator.
• < 5% blasts in bone marrow.
• Peripheral WBC count < 13,000/μL during the 28 days prior to cycle 5 day 1 (C5D1).
• Part 2 Inclusion Criteria
• Participants are eligible to be included in Part 2 of the study only if all the following criteria apply:
• Cohort A:
• Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.

Where it is running

• Hospital Universitari i Politecnic La Fe — Valencia, Spain (enrolling)
• University of Miami School of Medicine Sylvester Comprehensive Cancer Center (SCCC) — Miami, Florida, United States (enrolling)
• H. Lee Moffitt Cancer Center and Research Center — Tampa, Florida, United States (enrolling)
• Royal Melbourne Hospital — Melbourne, Victoria, Australia (enrolling)
• St Vincent's Hospital Melbourne — Melbourne, Victoria, Australia (enrolling)
• Fakultni nemocnice Kralovske Vinohrady — Prague, Czechia (enrolling)
• CHU de Nantes - Hotel Dieu — Nantes, France (enrolling)
• CHU Nice - Hopital de l'Archet 1 — Nice, France (enrolling)
• Hopital Saint-Louis — Paris, France (enrolling)
• CH Rene-Dubos — Pontoise, France (enrolling)
• CHU de Bordeaux - Hopital Haut-Leveque — Talence, France (enrolling)
• Klinikum Bayreuth GmbH — Bayreuth, Germany (enrolling)
• Marien Hospital Dusseldorf GMBH — Düsseldorf, Germany (enrolling)
• Klinikum Esslingen GmbH — Esslingen am Neckar, Germany (enrolling)
• Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz — Mainz, Germany (enrolling)
• Sheba Medical Center - Sheba Fund for Health Services and Research — Ramat Gan, Israel (enrolling)
• Hospital Universitario Central de Asturias — Barcelona, Spain (enrolling)
• Hospital Universitario Vall d'Hebron — Barcelona, Spain (enrolling)
• ICO l'Hospitalet - Hospital Duran i Reynals — Barcelona, Spain (enrolling)
• Hospital Universitario de Salamanca — Salamanca, Spain (enrolling)
• City of Hope National Medical Center — Duarte, California, United States (enrolling)
• Border Medical Oncology Research — Albury, New South Wales, Australia (enrolling)
• Tweed Hospital — Tweed Heads, New South Wales, Australia (enrolling)
• Westmead Hospital — Westmead, New South Wales, Australia (enrolling)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)

Full record on ClinicalTrials.gov

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