Идёт набор NCT06716138

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

Фаза I С лечением Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

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: ANS03.
Кому может быть актуально: Состояния в реестре: Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration. 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: США, 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 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS03 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

Обзор

This is a first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03 as monotherapy.

Вмешательства

Препарат ANS03
ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).

Первичные конечные точки

Incidence of Adverse Events (AEs) [Срок оценки: From the time of first dose to 28 days post last dose of ANS03]
Incidence of Serious Adverse Events (SAEs) [Срок оценки: From time of first dose to 28 days post last dose of ANS03]
Incidence of dose-limiting toxicities (DLT) as defined in the protocol [Срок оценки: From time of first dose of ANS03 to end of DLT period (approximately 30 days)]
Incidence of baseline laboratory finding, ECG and vital signs changes [Срок оценки: From time of first dose to 28 days post last dose of ANS03]
Proportion of patients with radiological response (ORR) [Срок оценки: From date of first dose of ANS03 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)]

Вторичные конечные точки (11)

Objective Response Rate (ORR) [Срок оценки: From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)]
Duration of Response (DoR) [Срок оценки: From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)]
Disease Control Rate (DCR) [Срок оценки: From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)]
Progression free Survival (PFS) [Срок оценки: From date of first dose of ANS03 up until date of progression or death due to any cause (approximately 2 years)]]
Overall Survival (OS) [Срок оценки: From date of first dose of ANS03 up until the date of death due to any cause (approximately 2 years)]
Pharmacokinetics of ANS03: Plasma PK concentrations [Срок оценки: From date of first dose up until 28 days post last dose]
Pharmacokinetics of ANS03: Area under the concentration time curve (AUC) [Срок оценки: From date of first dose up until 28 days post last dose]
Pharmacokinetics of ANS03: Maximum plasma concentration of the study drug (C-max) [Срок оценки: From date of first dose up until 28 days post last dose]
Pharmacokinetics of ANS03: Time to maximum plasma concentration of the study drug (T-max) [Срок оценки: Frame: From date of first dose up until 28 days post last dose]
Pharmacokinetics of ANS03: Clearance [Срок оценки: From date of first dose up until 28 days post last dose]
Pharmacokinetics of ANS03: Half-life [Срок оценки: From date of first dose up until 28 days post last dose]

Критерии участия

Критерии включения

Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2
Life expectancy ≥ 12 weeks
Measurable disease per RECIST v1.1
Adequate organ and marrow function as defined in the protocol
With documentation of ROS1 or NTRK alteration

Критерии исключения

Active infection including tuberculosis and HBV, HCV or HIV
Known active or untreated CNS metastases
Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
Participants with serious cardiovascular or cerebrovascular diseases

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

Здоровые добровольцы: Нет