NCT06218771招募中1 期
A Phase Ib Clinical Trial of TQB3454 Tablets in Patients With Blood Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 17
- 主要终点
- The rate of all adverse events (AEs), serious adverse events (SAEs)
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety of TQB3454 tablets in patients with acute myeloid leukemia and myelodysplastic syndrome, and determine the phase II recommended dose.
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
- •Patients voluntarily joined the study and signed informed consent with good compliance.
- •Men and women; The expected survival is ≥3 months.
- •Negative serum/urine pregnancy test within 7 days prior to initial dose and must be non-lactating; Women of childbearing age agree to use contraception (such as an intrauterine device, birth control pill or condom) during the study and for six months after the study completion; Men agreed to use contraception during the study period and for six months after the end of the study.
- •The major organs are functioning well;
- •For Relapsing/refractory acute myeloid leukemia (AML):
- •According to the classification criteria for Hematopoietic and lymphoid tissue tumors revised by the World Health Organization (WHO) in 2016, AML confirmed by bone marrow cell morphology, excluding acute promyelocytic leukemia (APL).
- •≥18 years old; Eastern Cooperative Oncology Group (ECOG) score is 0~
- •Blood biochemical examination:
- •i: Total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN), liver infiltration ≤3×ULN in Gilbert syndrome patients or tumor diseases; ii: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; ALT and AST≤5×ULN if liver infiltration was associated.
- •For myelodysplastic syndrome (MDS) with higher risk:
- •MDS patients were confirmed by bone marrow cell morphology and cytogenetics and met the classification criteria of hematopoietic and lymphoid tissue tumors revised by WHO in
- •≥18 years old; ECOG score is 0~
- •c. Blood biochemical examination:
- •i: Total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN), liver infiltration ≤3×ULN in Gilbert syndrome patients or tumor diseases.
- •ii: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; ALT and AST≤5×ULN if concomitant with liver infiltration.
排除标准
- •Tumor diseases and history:
- •The tumor has or is suspected to involve the central nervous system, or primary Central nervous system leukemia.
- •Present or present with other malignant tumors within 3 years prior to the first dose. Except the following conditions: for other malignancies treated with a single operation, achieving a 5-year continuous disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)].
- •Severe life-threatening complications of leukemia, such as uncontrolled bleeding, hypoxia or shock pneumonia, and disseminated intravascular coagulation.
- •Previous antitumor therapy:
- •Received National Medical Products Administration (NMPA) approved Chinese patent drugs with anticancer indications specified in the drug label within 2 weeks prior to initial administration.
- •Toxicities associated with previous antineoplastic therapy did not return to CTCAE≤1, except for hair loss, fatigue and poor appetite.
- •Associated diseases and history:
- •Abnormal liver.
- •Renal abnormalities.
- •Gastrointestinal abnormalities.
- •Cardio-cerebrovascular abnormalities.
- •Immune-related history.
- •Lung disease.
- •Comorbidities that were severe or poorly controlled and, in the investigator's judgment, significantly compromised patient safety or hindered study completion.
- •Risk of bleeding.
- •History of drug abuse or drug abuse.
- •Participated in clinical trials of other drugs within the past 30 days;
- •It is estimated that the patient's compliance to participate in this clinical study is insufficient.
研究组 & 干预措施
TQB3454 Tablets
Experimental
TQB3454 Tablets, orally administered, 28 days as a treatment cycle.
干预措施: TQB3454 Tablets (Drug)
结局指标
主要结局
The rate of all adverse events (AEs), serious adverse events (SAEs)
时间窗: Up to 80 weeks
Proportion of patients with adverse events/serious adverse events, as defined by Common Terminology Criteria for Adverse Events (CTCAE5.0)
The severity of all adverse events (AEs), serious adverse events (SAEs)
时间窗: Up to 80 weeks
The severity of adverse events/serious adverse events, as defined by Common Terminology Criteria for Adverse Events (CTCAE5.0)
Incidence of abnormal laboratory values
时间窗: Up to 80 weeks
The proportion of patients with abnormal laboratory examination indicators mainly included blood routine, blood routine, blood biochemistry, coagulation function, thyroid function, myocardial enzyme profile, urine routine, stool routine and 12-lead electrocardiogram.
次要结局
- Complete response (CR) rate(Up to 80 weeks)
- Overall response rate (ORR)(Up to 80 weeks)
- Progression-free survival (PFS)(Up to 80 weeks)
- Leukemia-free survival(Up to 80 weeks)
- Correlation between 2-hydroxyglutaric acid (2-HG) and efficacy(Pre-dose (baseline). Pre-dose on Cycle 1 Day 14, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, Cycle 4 Day 28, Cycle 5 Day 28, Cycle 6 Day 28, 28 days as a cycle)
- Peak concentration (Cmax)(Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.)
- Area under blood concentration-time curve (AUC 0-24h)(Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.)
- Overall survival (OS)(Up to 80 weeks)
- Functional Assessment of Chronic Illness (FACIT) fatigue Scale(Up to 80 weeks)
- Quality of life score(Up to 80 weeks)
- Peak time (Tmax)(Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.)
- Steady-state apparent volume of distribution (Vz/F)(Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.)
- Transfusion-independent improvement(Up to 80 weeks)
- Duration of response (DOR)(Up to 80 weeks)
- Time to CR+CRh(Up to 80 weeks)
- Event-free survival (EFS)(Up to 80 weeks)
- CR+CRh duration(Up to 80 weeks)
- Steady-state blood trough concentration (Cmin,ss)(Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.)
- Complete response (CR) + Complete response with partial hematological recovery (CRh)(Up to 80 weeks)
- CR duration(Up to 80 weeks)
研究者
研究点 (17)
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