Clinical Trial of TQB3002 in Patients With Advanced Cancers

Официальное название

A Phase I Clinical Study of TQB3002 in Patients With Advanced Cancers

Обзор

This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers

Вмешательства

• Препарат TQB3002 Tablets
  TQB3002 is a fourth-generation small molecule Epidermal growth factor receptor (EGFR) inhibitor, which inhibits relevant tyrosine kinase activity and intracellular phosphorylation process by competitively binding to Adenosine triphosphate (ATP) site of intracellular tyrosine kinase binding domain, thereby inhibiting EGFR downstream signaling, ultimately achieving the purpose of inhibiting tumor growth.

Первичные конечные точки

• Dose Limiting Toxicity (DLT) [Срок оценки: During the first 28 days]
• Maximum tolerated dose (MTD) [Срок оценки: During the first 28 days]

Вторичные конечные точки (5)

• Half-life (T1/2) [Срок оценки: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration]
• The area under the curve (AUC) [Срок оценки: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration]
• Apparent Plasma Clearance (CL) [Срок оценки: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration]
• Apparent volume of distribution (Vz) [Срок оценки: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration]
• Minimum concentration (Cmin) [Срок оценки: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration]

Критерии участия

Критерии включения

• Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；
• Age: ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months；
• Histologically or cytologically diagnosed with advanced cancers
• Subjects with advanced malignancies who have failed standard therapy or lack effective treatment
• Major organs are functioning well；
• Female and male subjects of childbearing potential should agree to practice contraception for the duration of the study and for 6 months after the end of the study.

Критерии исключения

• Current concomitant presence of other malignancies within 5 years prior to the first dose；
• Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy
• Significant surgical treatment, biopsy, or significant traumatic injury within 4 weeks prior to the first dose
• Long-term unhealed wounds or fractures
• Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose
• Swallowing dysfunction, active gastrointestinal diseases or other diseases that significantly affect the absorption, distribution, metabolism and excretion of the study drug, or previous subtotal gastrectomy
• A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder
• Subjects with any severe and/or uncontrolled disease

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 · 11 центров

• Guangdong Provincial People's Hospital — Гуанчжоу
• Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center — Шэньчжэнь
• Henan Cancer Hospital — Чжэнчжоу
• Jiangsu Province Hospital — Нанкин
• The First Affiliated Hospital Of Nanchang University — Nanchang
• Shanghai Pulmonary Hospital — Шанхай
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi’an
• The First Affiliated Hospital of Xi'an Jiao Tong University — Xi’an
• … и ещё 3 центра

Идентификаторы

NCT: NCT06662760 · TQB3002-I-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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