NCT06672263尚未招募1 期
Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.5 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Phase II recommended doses (RP2D)
研究概览
简要总结
Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
TQB3911 tablets
Experimental
Once a day for 28 days as a treatment cycle
干预措施: TQB3911 tablets (Drug)
结局指标
主要结局
Phase II recommended doses (RP2D)
时间窗: Baseline up to 24 months
The dosage of drug therapy recommended for use in the second phase of clinical trials (i.e., phase II clinical trials).
Dose-limiting toxicity (DLT)
时间窗: Up to 1 month
Adverse events that meet the protocol definition of dose-limiting toxic event timing were evaluated according to the Common Terminology Criteria for Adverse Events 5.0.
次要结局
- Incidence and severity of adverse event (AE) and serious adverse event (SAE), and abnormal laboratory test indicators(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(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(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(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(They were evaluated every 12 weeks (±7 days) for 96 weeks and every 24 weeks (±7 days) after 96 weeks)
- Molecular reaction(They were evaluated every 12 weeks (±7 days) for 96 weeks and every 24 weeks (±7 days) after 96 weeks)
- Progression free survival(They were evaluated every 12 weeks (±7 days) for 96 weeks and every 24 weeks (±7 days) after 96 weeks)
- Overall survival(They were evaluated every 12 weeks (±7 days) for 96 weeks and every 24 weeks (±7 days) after 96 weeks)
- Peak concentration Cmax(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(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.)
研究者
研究点 (5)
Loading locations...
相似试验
招募中
1 期
A Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) .Small Lymphocytic LymphomaChronic Lymphocytic LeukemiaNCT05959694Chia Tai Tianqing Pharmaceutical Group Co., Ltd.107
已完成
1 期
A Clinical Trial of TQ-A3334 Tablet After Multiple Administration in Adult SubjectsHepatitis BNCT06160895Chia Tai Tianqing Pharmaceutical Group Co., Ltd.40
尚未招募
1 期
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQ-B3234 in Patients With Type I NeurofibromatosisType I NeurofibromatosisNCT05107037Chia Tai Tianqing Pharmaceutical Group Co., Ltd.120
招募中
1 期
A Study of TQB3454 Tablets in Patients With Blood TumorsMyelodysplastic SyndromesAcute Myeloid LeukemiaNCT06218771Chia Tai Tianqing Pharmaceutical Group Co., Ltd.80
Unknown
1 期
A Study of CSPCHA131 in Patients With Advanced Solid TumorAdvanced Solid TumorsNCT04325711CSPC ZhongQi Pharmaceutical Technology Co., Ltd.100