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

NCT06594965 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: HS-20106-201
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myelodysplastic Syndromes; Anemia; MDS; Bone Marrow Disease

Keywords

MDS; HS-20106; KER-050; fusion protein; TGF-β

Outcome Measures

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

  Week 1 through Week 24

Secondary Outcomes (11)

• HI-E Duration

  Throughout the study period, assessed up to 48 weeks.

• Time to HI-E

  Week 1 through Week 24

• Proportion of participants with RBC-TI ≥ 8 Weeks（cohort 2 only）

  Week 1 through Week 24

• Duration of TI response

  Throughout the study period, assessed up to 48 weeks.

• Time to RBC-TI ≥ 8 weeks

  Week 1 through Week 24

Study Arms (2)

HS-20106 Cohort 1

EXPERIMENTAL

Part A: Non-transfusion dependent population

Drug: HS-20106

HS-20106 Cohort 2

EXPERIMENTAL

Part A: Transfusion-Dependent Population（low-transfusion burden (LTB) and high-transfusion burden (HTB)）

Drug: HS-20106

Interventions

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.

HS-20106 Cohort 1; HS-20106 Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Each cohort is defined as:
• Cohort 1： In NTD participants, having received no red blood cell (RBC) transfusions within 16 weeks Hgb concentration between 60 and 100g/L.
• Cohort 2： In LTB participants, having received an average of \< 4 units of RBC transfused within 8 weeks (i.e., total blood transfused over 16 weeks/2) Hgb concentration between 60 and 100 g/L.
• In HTB participants, having received an average of ≥ 4 units of RBC transfused within 8 weeks (i.e., total blood transfused over 16 weeks/2) Hgb concentration between 60 and 100 g/L.
• 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.

You may not qualify if:

• 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.
• Treatment within 4 weeks prior to C1D1 with:
• \) Erythropoiesis stimulating agent (ESA) OR 2) Granulocyte colony-stimulating factor (G-CSF) OR 3) Granulocyte-macrophage colony-stimulating factor (GM-CSF) 6. Iron chelation therapy if initiated within 8 weeks prior to C1D1. 7. Vitamin B12 therapy if initiated within 8 weeks prior to C1D1. 8. Treatment with another investigational drug or device or approved therapy for investigational use \< or = 4 weeks prior to C1D1, or if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer.
• \. Peripheral blood white blood cell count \>13.0 x 10\*9/L. 10. Neutrophil count \< 1.0 x 10\*9/L. 11. Platelet count \> 450 x 10\*9/L or \< 30 x 10\*9/L. 12. Transferrin saturation \< 15%. 13. Ferritin \< 15 μg/L. 14. Folate \< 4.5 nmol/L (\< 2.0 ng/mL). 15. Vitamin B12 \< 148 pmol/L (\< 200 pg/mL). 16. Estimated glomerular filtration rate (GFR) \< 40 mL/min/1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\].
• \. Pregnant or lactating females

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Anemia; Bone Marrow Diseases

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Zhijian Xiao, PhD

CONTACT

(0086)022-23909184; xiaozj_mds026@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 30, 2024
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)