Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers

Официальное название

A Phase I Clinical Study of TQB2922 for Injection in Patients With Advanced Cancers

Обзор

This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers

Вмешательства

• Препарат TQB2922 for injection
  TQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle

Первичные конечные точки

• Dose limiting toxicity (DLT) [Срок оценки: During the first treatment cycle (28 days).]
• Maximum tolerated dose (MTD) [Срок оценки: During the first treatment cycle (28 days).]
• Adverse events (AEs) rate [Срок оценки: From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.]
• Adverse events (AEs) severity [Срок оценки: From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.]

Вторичные конечные точки (9)

• Half-life (T1/2) [Срок оценки: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.]
• The area under the curve (AUC) [Срок оценки: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.]
• Apparent plasma clearance (CL) [Срок оценки: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.]
• Apparent volume of distribution (Vz) [Срок оценки: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.]
• Minimum concentration (Cmin) [Срок оценки: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.]
• Objective response rate (ORR) [Срок оценки: Up to 2 years.]
• Duration of response (DOR) [Срок оценки: Up to 2 years.]
• Progression-free survival (PFS) [Срок оценки: Up to 2 years.]
• Immunogenicity of TQB2922 [Срок оценки: From the time of informed consent to 90 days after the last dose.]

Критерии участия

Критерии включения

• Subjects voluntarily join this study, sign the informed consent form, and have good compliance；
• Age: 18-75 years; 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 during the study and until 6 months after the completion of the study.

Критерии исключения

• Current concomitant or ever presented with other malignancies within 2 years prior to the first dose;
• Unresolved toxicity of Grade 1 or above according to CTCAE due to any prior anti-tumor therapy;
• Significant surgical treatment, biopsy, or significant traumatic injury within 28 days 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;
• A history of psychotropic drug abuse and cannot be abstained, or have a mental disorder;
• Subjects with any severe and/or uncontrolled disease;
• History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;
• Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2922 for injection or its excipients;
• According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.

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 · 17 центров

• Chongqing University Cancer Hospital — Чунцин
• Sun Yat-sen University Cancer Center — Гуанчжоу
• The first affiliated hospital of Guangzhou medical university — Гуанчжоу
• Harbin Medical University Cancer Hospital — Харбин
• Henan Cancer Hospital — Чжэнчжоу
• Henan Provincine People's Hospital — Чжэнчжоу
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• The Second Xiangya Hospital of Central South University — Чанша
• … и ещё 9 центров

Идентификаторы

NCT: NCT06188624 · TQB2922-I-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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