The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias

Официальное название

A Phase 1/2, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias

Обзор

The most common types of acute leukaemia are acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). AML is a heterogenous clonal disorder of haemopoietic progenitor cells and the most common and severe malignant leukemia in adults and is responsible for the highest mortality from leukemia. ALL is a neoplasm characterized by the growth of malignant lymphoblasts of the B or T lineage, leading to an inhibition of proliferation of the normal blood cell lineages. The primary objectives of this study are investigating the safety, tolerability, and the MTD of LBS-007. The secondary objectives are to assess the efficacy and to determine the pharmacokinetics (PK) of LBS-007. The exploratory objective is to study and correlate the changes in surrogate biomarkers in response to treatment.

Вмешательства

• Препарат LBS-007
  Open Label.

Первичные конечные точки

• Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5. [Срок оценки: From baseline through 28 days after end of last treatment cycle (up to 12 months)]
• Recommended Phase 2 Dose (RP2D) of LBS-007 in the subject population. [Срок оценки: From baseline through 28 days after end of last treatment cycle (up to 12 months)]

Вторичные конечные точки (4)

• Maximum Plasma Concentration (Cmax) of LBS-007 in plasma. [Срок оценки: Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.]
• Time to Maximum Plasma Concentration (Tmax) of LBS-007 in plasma. [Срок оценки: Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.]
• Area under the drug concentration-time curve (AUC) of LBS-007 in plasma. [Срок оценки: Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.]
• Efficacy of LBS-007 assessed by bone marrow and peripheral blood. [Срок оценки: From baseline through 28 days after end of last treatment cycle (up to 12 months)]

Критерии участия

Критерии включения

• Male or female subjects greater than 18 years old, inclusive.
• Pathologically confirmed diagnoses of Relapsed or resistant AML or ALL.
• Patients who are ineligible for standard therapies that are anticipated to result in durable remission or cure, or who have no known therapy options of documented benefit.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Критерии исключения

• Concomitant chemotherapy, radiation therapy, or immunotherapy.
• Receiving any other investigational agents concurrently or within 30 days prior to screening.
• Patient has acute promyelocytic leukaemia or leukemia with active CNS involvement.
• History of another active malignancy with 2 years prior to study entry, basal cell skin cancer and previous carcinoma in treated curatively.
• Patient with mental deficits and/or psychiatric history that precludes them from giving informed consent or from following protocol.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 6 центров

• Wollongong Private Hospital — Wollongong
• Pindara Private Hospital — Benowa
• The Royal Adelaide Hospital — Adelaide
• The Alfred Hospital — Melbourne
• Hollywood Private Hospital — Nedlands
• Q Medical Conselling — Perth

США · 5 центров

• Moffitt Cancer Center — Tampa
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago
• The University of Kansas Hospital — Fairway
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore
• UNC Hospitals, The University of North Carolina at Chapel Hill — Chapel Hill

Китай · 3 центра

• The First Affiliated Hospital of Xinxiang Medical University — Xinxiang
• Jining No.1 People's Hospital — Jining
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Тяньцзинь

Тайвань · 3 центра

• China Medical University Hospital — Taichung
• National Cheng Kung University Hospital — Tainan
• National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT05756322 · LBS-007-CT01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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