Clinical Trial of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers

Официальное название

A Phase I Clinical Study to Evaluate The Safety and Pharmacokinetics of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers

Обзор

This is a Phase I clinical study aimed at evaluating the safety and pharmacokinetics of TQB2922 subcutaneous injection in patients with advanced cancers.

Вмешательства

• Препарат TQB2922 injection (subcutaneous injection)
  TQB2922 is a bispecific antibody against Epidermal Growth Factor Receptor (EGFR)/c-Met.

Первичные конечные точки

• Time to Peak Concentration [Срок оценки: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)]
• Peak concentration [Срок оценки: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)]
• half-life (T1/2) [Срок оценки: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)]
• The area under the curve (AUC0-∞） [Срок оценки: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)]
• The area under the curve (AUC0-t) [Срок оценки: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)]
• Elimination Rate [Срок оценки: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)]
• Apparent Oral Clearance [Срок оценки: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)]
• Apparent Volume of Distribution [Срок оценки: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)]
• Trough Concentration [Срок оценки: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)]
• Accumulation Ratio [Срок оценки: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)]

Вторичные конечные точки (5)

• Adverse Events (AE) rate [Срок оценки: From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first]
• Objective Response Rate (ORR) [Срок оценки: Up to 2 years]
• Duration of Response (DOR) [Срок оценки: Up to 3 years]
• Progression-free survival (PFS) [Срок оценки: Up to 3 years]
• Incidence of anti-drug antibody (ADA) [Срок оценки: From the time of informed consent signed through 90 days after the last dose.]

Критерии участия

Критерии включения

• Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；
• 18-75 yeas old；
• Eastern Cooperative Oncology Group Performance Status (ECOG) score: 0-1;
• Expected survival of more than 12 weeks；
• Histologically or cytologically diagnosed with advanced non-squamous non-small cell lung cancer
• Subjects in the monotherapy introduction stage need to have received standard treatment or lack effective treatment.
• There must be at least one measurable lesion within the radiotherapy area that can be clearly classified as progressive according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1) criteria.
• 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；
• At the time of initiating the study of treatment, the adverse reactions caused by previous anti-tumor treatments failed to recover to a CTCAE 5.0 score of grade 1 or below.
• Patients who had received major surgical treatment within 4 weeks prior to the first study, had obvious traumatic injuries, or were expected to undergo major surgery during the study treatment period, or had long-term unhealed wounds or fractures.
• Hyperactive or venous thrombosis events occurred within 6 months before the first administration;
• Major cardiovascular diseases;
• Active hepatitis
• Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders.
• There was an active infection (≥ Common Terminology Criteria for Adverse Events version 5.0 (CTCAE5.0) score of grade 2) within 2 weeks before the first administration;
• Patients with renal failure requiring hemodialysis or peritoneal dialysis;
• Patients who have a history of immune deficiency.
• Patients who have epilepsy and need treatment;
• Evidence of a previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any clinically active interstitial lung disease.
• Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first treatment.
• Pregnant or lactating women.
• There is any serious or uncontrolled systemic 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

• Sun Yat-sen University Cancer Center — Гуанчжоу
• Henan Cancer Hospital — Чжэнчжоу
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• Hunan Cancer Hospital — Чанша
• Nanjing Drum Tower Hospital — Нанкин
• The First Affiliated Hospital of Nanchang University — Nanchang
• Affiliated Zhongshan Hospital of Dalian University — Dalian
• Shandong Cancer Hospital — Цзинань
• … и ещё 3 центра

Идентификаторы

NCT: NCT07260708 · TQB2922-I-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗