A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors

Официальное название

A Phase I Clinical Study of Tolerability and Pharmacokinetics of TQB3107 Tablets in Patients With Malignant Tumors

Обзор

TQB3107 is an target inhibitor that binds to target to induce apoptosis and inhibits the proliferation of a variety of tumor cells. This is a clinical study to evaluate the safety and tolerability of TQB3107 tablets in subjects with advanced malignancies, to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) (if any), and the recommended dose for Phase II (RP2D).

Вмешательства

• Препарат TQB3107 Tablets
  TQB3107 Tablets is a selective target inhibitor.

Первичные конечные точки

• Dose Limiting Toxicity (DLT) [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]
• Maximum tolerated dose (MTD) [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]
• Phase II Recommended Dose (RP2D) [Срок оценки: Baseline up to 24 months]

Вторичные конечные точки (11)

• Elimination half-life (t1/2) [Срок оценки: Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.]
• Time to Peak (Tmax) [Срок оценки: Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.]
• Peak Concentration (Cmax) [Срок оценки: Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.]
• Area under the plasma concentration-time curve (AUC0-last) [Срок оценки: Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.]
• Steady-state peak concentration (Css-max) [Срок оценки: Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.]
• Steady-state trough concentration (Css-min) [Срок оценки: Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.]
• Objective Response Rate (ORR) [Срок оценки: UP to 3 years]
• Disease Control Rate (DCR) [Срок оценки: UP to 3 years]
• Duration of Response (DOR) [Срок оценки: UP to 3 years]
• Progression-free survival (PFS) [Срок оценки: UP to 3 years]
• Overall Survival (OS) [Срок оценки: UP to 3 years]

Критерии участия

Критерии включения

• 18 years ≤ age≤ 75 years (calculated from the date of signing the informed consent); Score 0\~1 point, estimated survival ≥ 3 months；
• Advanced malignant tumor；
• The major organs are functioning well；
• Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception throughout the study and for 6 months after the study ends;
• Subjects voluntarily participated in this study, signing the informed consent form and demonstrating good compliance.

Критерии исключения

• Hematologic malignancy has or is suspected to involve the central nervous system, or primary central nervous system lymphoma;
• Received any anti-cancer therapy such as major surgery, chemotherapy and/or radiotherapy, immunotherapy, or targeted therapy within 4 weeks prior to the first dose;
• Combined with severe or not well-controlled diseases, which the investigator judges to be at greater risk of entering this study；
• Those with a history of drug addiction or substance abuse；
• According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subjects 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 · 12 центров

• Sun Yat-sen University Cancer Cen — Гуанчжоу
• The Fifth Affiliated Hospital Sun Yat-sen University — Zhuhai
• The Affiliated Hospital of Chengde Medical College — Chengde
• Harbin Medical University Cancer Hospital — Харбин
• Hunan Cancer Hospital — Чанша
• The First People's Hospital Of Changzhou — Changzhou
• Shandong Medical And Pharmaceutical University Hospital — Binzhou
• Fudan University Shanghai Cancer Center — Шанхай
• … и ещё 4 центра

Идентификаторы

NCT: NCT06413953 · TQB3107-I-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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