A Multicenter, Open Label Phase I Clinical Trial Evaluating the Safety and Pharmacokinetics of TQB2252 Injection in Subjects With Advanced Malignant Tumors

Обзор

This study is a multicenter, single arm, and open design Phase I clinical trial aimed at evaluating the safety, Pharmacokinetics (PK) characteristics, immunogenicity, and preliminary efficacy of TQB2252 injection in subjects with advanced malignant tumors.

Вмешательства

• Препарат TQB2252 injection
  TQB2252 injection is a compound preparation of TQB2223 monoclonal antibody (LAG-3) and penpulimab (PD-1), with a specification of 300mg TQB2223 monoclonal antibody and 100mg (20ml) penpulimab per bottle.

Первичные конечные точки

• Adverse events (AE) rate [Срок оценки: From date of the first dose until the date of 28 days after last dose or new anti-tumor treatment, whichever came first.]

Вторичные конечные точки (7)

• Time to reach maximum observed plasma concentration (Tmax) [Срок оценки: Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)]
• Maximum Plasma Concentration (Cmax) [Срок оценки: Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)]
• Elimination half-life (t1/2) [Срок оценки: Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)]
• Objective Response Rate (ORR) [Срок оценки: up to 2 years]
• Progression-free survival (PFS) [Срок оценки: up to 2 years]
• Disease control rate (DCR) [Срок оценки: up to 2 years]
• Duration of Response (DOR) [Срок оценки: up to 2 years]

Критерии участия

Критерии включения

• The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance;
• 18 years old ≤ 75 years old (calculated from the date of signing the informed consent form);
• Electrocorticogram (ECOG) score ranges from 0 to 1 points;
• Expected survival is greater than 12 weeks；
• Confirmed to have at least one measurable lesion according to RECIST 1.1 (solid tumor) or Lugano 2014 (lymphoma) criteria；
• Late stage malignant tumor subjects who have failed standard treatment or lack effective treatment；
• Women of childbearing age should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study; Men should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study period.

Критерии исключения

• Has experienced or currently has other malignant tumors within the past 5 years prior to the first use of medication;
• There are multiple factors that affect diseases related to intravenous injection and venous blood collection;
• The adverse reactions of previous anti-tumor treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score of ≤ 1;
• Individuals who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication;
• Subjects who experience any bleeding or bleeding events ≥ CTCAE grade 3 within 4 weeks prior to the first administration;
• An arterial/venous thrombotic event occurred within 6 months prior to the first administration;
• Active viral hepatitis with poor control;
• Active syphilis infected individuals in need of treatment;
• History of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia;
• Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
• Diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy due to a history of hepatic encephalopathy;
• Previously experienced grade 3 or higher adverse reactions related to immunotherapy;
• Suffering from significant cardiovascular disease;
• Active or uncontrolled severe infections;
• Patients with renal failure requiring hemodialysis or peritoneal dialysis;
• History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases;
• Individuals with epilepsy who require treatment;
• Previously received treatment with similar anti-lag3 drugs.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangdong provincial people's hospital — Гуанчжоу

Идентификаторы

NCT: NCT06649656 · TQB2252-I-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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