A Study of BPI-460372 in Advanced Solid Tumor Patients

Официальное название

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-460372 in Advanced Solid Tumor Patients

Обзор

This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-460372 in solid tumor patients.

Вмешательства

• Препарат BPI-460372
  Subjects will receive BPI-460372 until disease progression

Первичные конечные точки

• The adverse events (AEs) [Срок оценки: Through the Phase I, approximately 24 months]
• The dose-limiting toxicity（DLT） [Срок оценки: Through the Phase I, approximately 24 months]
• Determine the Maximum Tolerated Dose (MTD) [Срок оценки: Through the Phase I, approximately 24 months]

Вторичные конечные точки (2)

• Evaluate the pharmacokinetics of BPI-460372 [Срок оценки: Time Frame: Through the Phase I, approximately 24 months]
• Evaluate the effectiveness of BPI-460372 [Срок оценки: Time Frame: Through the Phase I, approximately 24 months]

Критерии участия

Критерии включения

• Signed informed consent;
• Age ≥18, male and female patients；
• Expected survival ≥ 3 months；
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
• Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
• Dose expansion phase: histologically or cytologically confirmed locally advanced Malignant mesothelioma, Epithelioid hemangioendothelioma or other diagnosed solid tumor patients with NF2 defects, YAP/TAZ fusion, LATS1/2 mutations, and other Hippo signaling pathway abnormalities , who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
• Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1 or mRECIST v1.1 required for dose expansion phase;

Критерии исключения

• Patients who have previously received a TEAD inhibitor;
• Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation，etc；
• Patients with severe or unstable systemic disease, unstable/symptomatic CNS metastasis, meningeal metastasis and spinal cord compression，malignant tumors, cardiac disease, bleeding or embolic disease, infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;
• Pregnancy or lactation;
• Other conditions considered not appropriate to participate in this trial by the investigators.

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 · 11 центров

• Peking Union Medical College Hospital — Пекин
• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Affiliated Hospital of Hebei University — Baoding
• Harbin Medical University Cancer Hospital — Харбин
• Tongji Hospital Tongji Medical College of HUST — Ухань
• Hunan Cancer Hospital — Чанша
• China-Japan Union Hospital of Jilin University — Changchun
• Central Hospital Affiliated to Shandong First Medical University — Цзинань
• … и ещё 3 центра

Идентификаторы

NCT: NCT05789602 · BTP-661911

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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