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Набор скоро начнётся NCT06387420

A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia

Фаза I / Фаза II С лечением ACUTE MYELOID LEUKEMIA; AML

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AK117, Azacitidine, Venetoclax, Placebo.
Кому может быть актуально
Состояния в реестре: ACUTE MYELOID LEUKEMIA; AML. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Phase 1b/2 Study of AK117 (Anti-CD47 Antibody) in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia

Обзор

This is a phase 1b/2 study. All patients are diagnosed with Acute Myeloid Leukemia (AML), Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine + venetoclax in subjects with AML.

Вмешательства

  • Препарат AK117
    Subjects receive AK117 intravenously.
  • Препарат Azacitidine
    Subjects receive azacitidine subcutaneously.
  • Препарат Venetoclax
    Subjects receive venetoclax orally.
  • Другое Placebo
    Subjects receive placebo intravenously.

Первичные конечные точки

  • Phase 1b: Number of participants with dose limiting toxicity (DLT) [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]
  • Phase 1b/2: Number of participants with adverse events (AEs) [Срок оценки: Up to approximately 2 years.]
  • Phase 1b/2: Composite complete remission rate (CCR) [Срок оценки: Time Frame: Up to approximately 2 years]
Вторичные конечные точки (11)
  • Overall response rate (ORR) [Срок оценки: Up to approximately 2 years]
  • Time to response (TTR) [Срок оценки: Up to approximately 2 years]
  • Time to CCR (TTCCR) [Срок оценки: Up to approximately 2 years]
  • Duration of response (DoR) [Срок оценки: Up to approximately 2 years]
  • Duration of CCR (DoCCR) [Срок оценки: Up to approximately 2 years]
  • Rate of CCR Without Minimal Residual Disease (CCR MRD-) [Срок оценки: Up to approximately 2 years]
  • Event-free survival (EFS) [Срок оценки: Up to approximately 2 years]
  • Overall survival (OS) [Срок оценки: The time from C1D1 until death due to any cause]
  • Peak of Serum Concentration (Cmax) [Срок оценки: Up to approximately 2 years]
  • Anti-drug antibody (ADA) [Срок оценки: Up to approximately 2 years]
  • Receptor occupancy (RO) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

  • Age ≥ 18 years old at the time of enrolment.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0\~3, and 0\~2 are required for subjects ≥75 years old.
  • Has a life expectancy of at least 12 weeks.
  • Diagnosed as AML diagnosed according to WHO 2022 criteria.
  • Has adequate organ function.
  • All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.

Критерии исключения

  • Diagnosed with acute promyelocytic leukemia, BCR-ABL1-positive AML, myeloid sarcoma, mixed phenotype acute leukemia (MPAL), accelerated phase or blast crisis of Chronic Myeloid Leukemia.
  • has central nervous system leukemia (CNSL).
  • Favorable risk cytogenetics such as t(8;21), inv(16) or t(16;16) or t(15;17) as per the National Comprehensive Cancer Network (NCCN) Guidelines Version 6, 2023 for AML.
  • Previously diagnosed with another malignancy or have any evidence of residual disease.
  • Previous allogeneic hematopoietic stem cell transplant (allo-HSCT).
  • Prior treatment with any B-cell lymphoma 2 (Bcl-2) inhibitors, anti-CD47 or anti-SIRPα (signal regulatory protein alpha) agent.
  • Use strong or moderate cytochrome P450 (CYP) 3A inducers systemically within one week prior to enrollment, or currently require long-term treatment with a moderate to strong CYP3A inducer.
  • Previously diagnosed with MDS and treated with demethylating drugs.
  • Patients with known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure (New York Heart Association Class III or IV), decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders.
  • Other conditions where the investigator considers the patient inappropriate for enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & P — Тяньцзинь

Идентификаторы

NCT: NCT06387420 · AK117-206

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗