A Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia

Официальное название

Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia

Обзор

Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.

Вмешательства

• Препарат TQB3911 tablets
  TQB3911 is a small molecule BCR::ABL1 allosteric inhibitor. By occupying the myristyl binding site, TQB3911 recovers the inhibition of BCR::ABL1 fusion protein kinase activity, and ultimately inhibits the proliferation of tumor cells.

Первичные конечные точки

• Phase II recommended doses (RP2D) [Срок оценки: Baseline up to 24 months]
• Dose-limiting toxicity (DLT) [Срок оценки: Up to 1 month]

Вторичные конечные точки (10)

• Incidence and severity of adverse event (AE) and serious adverse event (SAE), and abnormal laboratory test indicators [Срок оценки: From the signing of informed consent for administration to 28 days after the last administration/start of the new antitumor therapy (whichever occurs first).]
• Peak time [Срок оценки: Single dose on days 1 to 3, day 8 of cycle 1, day 15 of cycle 1, day 22 of cycle 1, and day 2 to day 1, each cycle is 28 days.]
• C-QT Research [Срок оценки: Single dose: 1 hour, 0.5 hour, 10 minutes before dose and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours after dose.]
• Platelet count [Срок оценки: For the first six weeks, the assessment was weekly. Starting at week 6, assessments were performed at week 8 and every 4 weeks (±7 days) thereafter]
• The proportion of Philadelphia chromosomes in the metaphase of bone marrow cells [Срок оценки: They were evaluated every 12 weeks (±7 days) for 96 weeks and every 24 weeks (±7 days) after 96 weeks]
• Molecular reaction [Срок оценки: They were evaluated every 12 weeks (±7 days) for 96 weeks and every 24 weeks (±7 days) after 96 weeks]
• Progression free survival [Срок оценки: They were evaluated every 12 weeks (±7 days) for 96 weeks and every 24 weeks (±7 days) after 96 weeks]
• Overall survival [Срок оценки: They were evaluated every 12 weeks (±7 days) for 96 weeks and every 24 weeks (±7 days) after 96 weeks]
• Peak concentration Cmax [Срок оценки: Single dose on days 1 to 3, day 8 of cycle 1, day 15 of cycle 1, day 22 of cycle 1, and day 2 to day 1, each cycle is 28 days.]
• Plasma elimination half-life t1/2 [Срок оценки: Single dose on days 1 to 3, day 8 of cycle 1, day 15 of cycle 1, day 22 of cycle 1, and day 2 to day 1, each cycle is 28 days.]

Критерии участия

Критерии включения

• The subjects voluntarily joined the study, signed the informed consent, and had good compliance;
• Age: ≥18 years old (when signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-2; Expected survival of more than 3 months;
• During the screening period, the patients were identified as Chronic myelogenous leukemia-Chronic phase (CML-CP) or accelerated phase (AP) patients by bone marrow cell morphological examination, molecular biological examination or cytogenetic examination;
• Chronic myelogenous leukemia (CML) patients who are intolerant to Tyrosine kinase inhibitors (TKI) drugs or whose therapeutic effect is not satisfactory (that is, the therapeutic response evaluation result is failure)
• The main organs function well
• Female subjects of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male subjects should agree to use avoidance during the study period and for 6 months after the end of the study period.

Критерии исключения

• Had or was currently suffering from other malignant tumors within 5 years before the first medication
• Combined with active central nervous system leukemia
• Major surgical treatment and significant traumatic injury were received within 28 days before the start of study treatment
• Previous history of myocardial infarction, pulmonary hypertension, or angina pectoris within 3 months before the first medication, or clinically significant arrhythmias such as ventricular tachycardia, complete left bundle branch block, and high atrioventricular block
• Acute pancreatitis and a history of chronic pancreatitis within 12 months before the first medication
• History of interstitial lung disease, radiation pneumonia requiring steroid treatment, or drug-related pneumonia
• Patients with CML-CP who have achieved complete cytogenetic response (CCyR)
• Received live attenuated vaccine within 4 weeks before the first dose, or planned to receive live attenuated vaccine during study participation
• Use of drugs that may have caused QT prolongation or tip torsical tachycardia in the 7 days prior to initial administration, or continuation of these medications during the study period

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 · 5 центров

• Peking University People's Hospital — Пекин
• The First Affiliated Hospital of Guangxi Medical University — Nanning
• Henan Cancer Hospital — Чжэнчжоу
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай
• The First Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT06672263 · TQB3911-I-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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