A Study of HS-20106 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company
About this trial
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of HS-20106 on anemia in patients with very low, low or intermediate risk MDS.
Eligibility criteria
Qualifiers
Diagnosis of MDS according to World Health Organization (WHO) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease（IPSS-R ≤ 3.5）.
< 5% blasts in bone marrow and < 1% blasts in peripheral blood.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia.
Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.
Disqualifiers
Chromosome 5q deletion, del (5q).
Anemia caused by other reasons, such as iron deficiency anemia, megaloblastic anemia, aplastic anemia, renal anemia or blood loss.
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).
Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.
Trial design
Treatments tested in this trial
- HS-20106
Treatment groups
176 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov