NCT05610202Unknown1 期
Phase I Clinical Trial of Tolerability and Pharmacokinetics of TQB3702 Tablets in Hematologic Tumor Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. The purpose is to evaluate the tolerability and preliminary efficacy of TQB3702 tablets in hematological tumor subjects.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
- •≥18 years old and ≤ 80 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
- •Clearly diagnosed recurrent / refractory hematological tumors that meet the WHO definition;
- •At least 1 measurable lesion for efficacy evaluation.
- •The function of main organs is normal.
- •Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; a negative serum pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
排除标准
- •Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS)s. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)].
- •Subjects with central nervous system aggression (CNS);
- •Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) or had active graft-versus-host disease (GVHD) requiring immunosuppressive therapy within 12 months before the first dose;
- •Multiple factors that affect the absorption of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction);
- •Unrelieved toxicity of ≥CTC AE grade 1 due to any previous treatment, excluding alopecia and fatigue;
- •Major surgical treatment, open biopsy, and significant traumatic injury were received within 28 days before the start of study treatment.
- •The presence of active or uncontrolled primary autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP);
- •Patients with evidence or history of bleeding constitution; Or any bleeding event (such as gastrointestinal bleeding) greater than or equal to CTC AE level 3 within 4 weeks before the first medication;
- •Subjects had an arteriovenous thrombosis event within 6 months.
- •Subjects have history of psychotropic substance abuse and are unable to abstain or have mental disorders;
- •Subjects with any severe and/or uncontrolled disease.
- •Within 2 weeks before the first treatment, the subjects had received proprietary Chinese medicines with anti-tumor indications specified in the NMPA approved drug instructions;
- •Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (investigator judgment);
- •Study treatment related: subjects received live or mRNA vaccines within 4 weeks before the first treatment or were scheduled to receive live or mRNA vaccines during the study;
- •Participated in clinical trials of other antitumor drugs within 4 weeks before the first treatment;
- •According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons.
研究组 & 干预措施
TQB3702 tablets
Experimental
TQB3702 tablets were administered orally, 28 days as a treatment cycle until the progressive diseases or the investigator judges that it is not suitable for subject to continue to take this medicine.
干预措施: TQB3702 tablets (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Baseline up to 104 weeks
To evaluate the maximum tolerated dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors.
Dose limited toxicity (DLT)
时间窗: Baseline up to 104 weeks
To evaluate the dose-limiting toxic dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors.
Recommended Phase II Dose (RP2D)
时间窗: Baseline up to 104 weeks
To evaluate the phase II recommended dose of TQB3702 tablets in the treatment of relapsed/refractory hematological tumors.
次要结局
- Time to Reach the Maximum Plasma Concentration (Tmax)-single dose(before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.)
- Elimination half-life (t1/2)-Single dose(before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 hours after administration.)
- Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)-Single dose(before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.)
- Time to Reach the Maximum Plasma Concentration (Tmax)-multiple dose(before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.)
- Maximum plasma concentration (Cmax)-Single dose(before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.)
- Maximum plasma concentration (Cmax)-Multiple dose(before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.)
- Elimination half-life (t1/2)-Multiple dose(before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.)
- Area under the plasma concentration-time curve from time zero to time t (AUC0-t)-Single dose(before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.)
- Area under the plasma concentration-time curve from time zero to time t (AUC0-t)-Multiple dose(before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.)
- Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)-Multiple dose(before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.)
- steady state area under the concentration-time curve over a dosing interval (AUCtau, ss)-single dose(before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.)
- steady state area under the concentration-time curve over a dosing interval (AUCtau, ss)-multiple dose(before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.)
- Minimum steady-state plasma drug concentration during a dosage interval (Css-min)-Single dose(before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.)
- Minimum steady-state plasma drug concentration during a dosage interval (Css-min)-multiple dose(before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.)
- Objective Response Rate (ORR)(Baseline up to 104 weeks)
- Complete Remission Rate (CRR)(Baseline up to 104 weeks)
- Duration of Response (DOR)(Baseline up to 104 weeks)
- Disease Control Rate (DCR)(Baseline up to 104 weeks)
- Progression Free Survival (PFS)(Baseline up to 104 weeks)
- Overall Survival (OS)(Baseline up to 104 weeks)
- Serious adverse events (SAE)(Baseline up to 104 weeks)
- Adverse events (AE)(Baseline up to 104 weeks)
- Bruton's tyrosine kinase (BTK) occupancy(Baseline up to 104 weeks)
研究者
研究点 (2)
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