Health TrialsbyHealthPanel

A Study of HS-20106 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

ConditionsMyelodysplastic SyndromesAnemiaMDSBone Marrow Disease
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • HS-20106

    Drug

    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.

Treatment groups

176 Participants
are divided into 2 treatment groups
Group A: HS-20106 Cohort 1Experimental treatment 1 intervention
Group B: HS-20106 Cohort 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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.
2

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
3

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
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hansoh BioMedical R&D Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: