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Идёт набор NCT04686682

A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors

Фаза I / Фаза II С лечением NSCLC SCLC CRPC ESCC

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: JAB-8263, JAB-8263.
Кому может быть актуально
Состояния в реестре: NSCLC, SCLC, CRPC, ESCC. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase I/IIa, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Patients With Advanced Malignant Tumors

Обзор

This is a Phase 1/2a, first-in-human, open-label study of JAB-8263, this study has two parts: solid tumor dose escalation and expansion study and hematology tumor dose escalation and expansion study. These two parts will determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT of JAB-8263 in treatment with patients with advanced solid tumors and hematology tumors separately. 30 subjects each will be enrolled.

Подробное описание

JAB-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal (BET) proteins.

The objectives of this study are:

To determine the maximum-tolerated dose (MTD) and assess the dose-limiting toxicity (DLT) of JAB-8263 as a single agent to adult subjects with advanced malignant tumors. To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic (PK) parameters and pharmacodynamics (PDc).To evaluate preliminary antitumor activity of JAB-8263

Вмешательства

  • Препарат JAB-8263
    Variable dose, orally Q2D with 28 days each cycle
  • Препарат JAB-8263
    RP2D dose, orally Q2D with 28 days each cycle

Первичные конечные точки

  • Number of participants with dose limiting toxicities [Срок оценки: Approximately 18 months]
Вторичные конечные точки (11)
  • Number of participants with adverse events [Срок оценки: Approximately 18 months]
  • Area under the curve [Срок оценки: Approximately 18 months]
  • Cmax [Срок оценки: Approximately 18 months]
  • Tmax [Срок оценки: Approximately 18 months]
  • T1/2 [Срок оценки: Approximately 18 months]
  • Objective response rate ( ORR ) [Срок оценки: Approximately 18 months]
  • Duration of response ( DOR ) [Срок оценки: Approximately 18 months]
  • Duration of response ( DCR ) [Срок оценки: Approximately 18 months]
  • CR without minimal residual disease rate (CR MRD-) [Срок оценки: Approximately 18 months]
  • Overall response rate [Срок оценки: Approximately 18 months]
  • Event-free survival( EFS) [Срок оценки: Approximately 18 months]

Критерии участия

Критерии включения

  • Subjects must meet all the following criteria in order to be included in the research study:
  • Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists.
  • Subjects with recurrent/refractory AML according to WHO 2016
  • Subjects with life expectancy ≥3 months.
  • Patients with solid tumor must have at least one measurable lesion as defined by RECIST v1.1.
  • Patients who have sufficient baseline organ function.

Критерии исключения

  • History (≤3 years) of cancer that is histologically distinct from the cancer under study.
  • Known serious allergy to investigational drug or excipients
  • Active brain or spinal metastases
  • History of pericarditis or Grade ≥2 pericardial effusion
  • History of interstitial lung disease.
  • History of Grade ≥2 active infections within 2 weeks
  • Known human immunodeficiency virus (HIV) infection
  • Seropositive for hepatitis B virus (HBV)
  • Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are not detectable.
  • Any severe and/or uncontrolled medical conditions
  • History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident
  • Impaired cardiac function or clinically significant cardiac diseases
  • QTcF >470 msec at screening
  • History of medically significant thromboembolic events or bleeding diathesis
  • Unresolved Grade >1 toxicity
  • History of malignant biliary obstruction
  • Pregnant or breast-feeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Tianjin — Тяньцзинь

Идентификаторы

NCT: NCT04686682 · JAB-8263-1002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗