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

Официальное название

Phase II Study on the Efficacy, Safety, and Pharmacokinetics of HS-20106 in Patients With IPSS-R Very Low-risk, Low-risk, or Moderate-risk Myelodysplastic Syndrome (MDS) Anemia

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат HS-20106
  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.

Первичные конечные точки

• Proportion of participants who achieve modified 2006 International Working Group (IWG)Hematologic Improvement-Erythroid (HI-E) response [Срок оценки: Week 1 through Week 24]

Вторичные конечные точки (11)

• HI-E Duration [Срок оценки: Throughout the study period, assessed up to 48 weeks.]
• Time to HI-E [Срок оценки: Week 1 through Week 24]
• Proportion of participants with RBC-TI ≥ 8 Weeks（cohort 2 only） [Срок оценки: Week 1 through Week 24]
• Duration of TI response [Срок оценки: Throughout the study period, assessed up to 48 weeks.]
• Time to RBC-TI ≥ 8 weeks [Срок оценки: Week 1 through Week 24]
• The proportion of participants with progression to intermediate-risk (IPSS-R score > 3.5) and higher MDS or AML. [Срок оценки: Week 1 through Week 24]
• Time to progression to intermediate-risk (IPSS-R score > 3.5) or higher MDS or AML. [Срок оценки: Week 1 through Week 24]
• Incidence of adverse events (AEs) and serious adverse events (SAEs). [Срок оценки: Throughout the study period, assessed up to 48 weeks.]
• Pharmacokinetic- AUC [Срок оценки: Throughout the study period, assessed up to 48 weeks.]
• Pharmacokinetic- Cmax [Срок оценки: Throughout the study period, assessed up to 48 weeks.]
• Antidrug antibodies (ADA) [Срок оценки: Throughout the study period, assessed up to 48 weeks.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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:

1\) 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.

9\. 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 \[CKD-EPI\].

17\. Pregnant or lactating females

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Institute of Hematology and Blood Diseases Hospital — Тяньцзинь

Идентификаторы

NCT: NCT06594965 · HS-20106-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗