Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors

Официальное название

A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors

Обзор

A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors

Вмешательства

• Препарат ICP-723
  ICP-723 tablet administered orally，once a day，for every 28 days as one cycle

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: Through study completion, an average of 4 years]

Вторичные конечные точки (12)

• ORR assessed by the investigator [Срок оценки: Through study completion, an average of 4 years]
• DCR as assessed by the investigator and the IRC [Срок оценки: Through study completion, an average of 4 years]
• Time to response (TTR) as assessed by the investigator and the IRC [Срок оценки: Through study completion, an average of 4 years]
• Duration of response (DOR) as assessed by the investigator and the IRC [Срок оценки: Through study completion, an average of 4 years]
• Progression-free survival (PFS) as assessed by the investigator and the IRC [Срок оценки: Through study completion, an average of 4 years]
• Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC [Срок оценки: Through study completion, an average of 4 years]
• central nervous system progression-free survival (CNS-PFS) as assessed by the investigator and IRC [Срок оценки: Through study completion, an average of 4 years]
• Overall survival (OS) [Срок оценки: Through study completion, an average of 4 years]
• The incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria [Срок оценки: Through study completion, an average of 4 years]
• The maximum plasma concentration observed (Cmax) [Срок оценки: Through study completion, an average of 4 years]
• Time of maximum observed plasma concentration (Tmax) [Срок оценки: Through study completion, an average of 4 years]
• Elimination half-life (t1/2) [Срок оценки: Through study completion, an average of 4 years]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Patients with advanced solid tumors or primary central nervous system (CNS) tumors harboring NTRK gene fusions as detected by the designated central laboratory, who received no previous NTRK inhibitor treatment;
• At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria.
• Organ functions meet the clinical criteria

Критерии исключения

• Patients with unstable primary central nervous system (CNS) tumors or CNS metastasis.
• Patients with abnormal QTc interval at screening, or other clinically significant abnormalities in electrocardiographic examination at the discretion of the investigator.
• Patient with recent anti-tumor and other treatment as stated in the protocol.
• Grade 1 or higher toxicities attributed to any previous treatment not yet recovered.
• Other conditions considered unsuitable for participation in this trial at the discretion of the investigator

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

Китай · 1 центр

• Sun Yat-Sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT05745623 · ICP-CL-00505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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