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.
Anemia is considered to be one of the most prevalent cytopenias in patients who have myelodysplastic syndromes, an umbrella term used to describe disorders relating to the ineffective production of red blood cells, white blood cells, and/or platelets. The goal of this study is to assess the efficacy, safety and PK of HS-20106 on anemia in Chinese patients with very low, low or intermediate risk MDS. Eligible subjects will be treated with HS-20106. Patients should be treated for at least 24 weeks in the core treatment period to assess their response to treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
176
HS-20106 administered subcutaneously every 4 weeks for up to 6 cycles. Eligible participants may be able to continue to receive subcutaneously administered HS-20106 after completing 6 cycles in the extended treatment period.
Institute of Hematology and Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Proportion of participants who achieve modified 2006 International Working Group (IWG)Hematologic Improvement-Erythroid (HI-E) response
* In NTD and LTB participants, response is defined as a mean hemoglobin (Hgb) increase of ≥ 15 g/L from Baseline during any consecutive 8-week period during the treatment period (in the absence of RBC transfusions) * In HTB participants, response is defined as a reduction by ≥ 4 units of RBCs transfused during any consecutive 8-week period on study compared with Baseline
Time frame: Week 1 through Week 24
HI-E Duration
the maximum duration of meeting the HI-E criteria for a subject who achieved HI-E.
Time frame: Throughout the study period, assessed up to 48 weeks.
Time to HI-E
the time from the first dose of study drug to the first achievement of HI-E.
Time frame: Week 1 through Week 24
Proportion of participants with RBC-TI ≥ 8 Weeks(cohort 2 only)
the proportion of participants who did not require RBC transfusion for at least 1 consecutive 8-week period.
Time frame: Week 1 through Week 24
Duration of TI response
the longest duration of response for participants who achieved RBC-TI of ≥ 8 weeks during the treatment period
Time frame: Throughout the study period, assessed up to 48 weeks.
Time to RBC-TI ≥ 8 weeks
the time from the first dose of study drug to the first achievement of RBC-TI ≥ 8 weeks.
Time frame: Week 1 through Week 24
The proportion of participants with progression to intermediate-risk (IPSS-R score > 3.5) and higher MDS or AML.
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Percentage of participants progressing to intermediate-risk (IPSS-R score \> 3.5) or higher MDS or AML throughout the course of the study
Time frame: Week 1 through Week 24
Time to progression to intermediate-risk (IPSS-R score > 3.5) or higher MDS or AML.
Time to progression was defined as the time between the first dose date and the first diagnosis of progression.
Time frame: Week 1 through Week 24
Incidence of adverse events (AEs) and serious adverse events (SAEs).
Type, frequency, severity of AEs and relationship of AEs to HS-20106
Time frame: Throughout the study period, assessed up to 48 weeks.
Pharmacokinetic- AUC
Pharmacokinetics of HS-20106
Time frame: Throughout the study period, assessed up to 48 weeks.
Pharmacokinetic- Cmax
Maximum plasma concentration of drug
Time frame: Throughout the study period, assessed up to 48 weeks.
Antidrug antibodies (ADA)
Frequency of antidrug antibodies and effects on efficacy, safety or PK
Time frame: Throughout the study period, assessed up to 48 weeks.