NCT06211751尚未招募1 期
A Phase Ib Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of TQB3909 Tablets Combined With TQB3702 Tablets in Hematologic Malignancy Subjects.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Dose limited toxicity (DLT)
研究概览
简要总结
This is an open, multi-cohort 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 safety and preliminary efficacy of TQB3909 tablets combined with TQB3702 tablets in hematologic malignancy 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, ≤75 years old (when signing informed consent form); Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
- •Subject population:
- •Dose escalation stage: non-Hodgkin's B-cell lymphoma;
- •Dose expansion stage: non-Hodgkin's lymphoma, etc.
- •At least 1 lesion / measurable disease 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 the completion of the study; 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 the completion of the study.
排除标准
- •Patients has occured or is currently having other malignant tumors within 5 years. The following two conditions can be included: other malignant tumors treated with a single operation to achieved 5 consecutive years of 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)] and papillary thyroid carcinoma.
- •Burkitt lymphoma, lymphoblastic lymphoma/leukemia, etc.
- •For cohort A and cohort B: Richter transformation occured.
- •Subjects with central nervous system (CNS) aggression;
- •Previously received allogeneic hematopoietic stem cell transplantation;
- •For Cohort B/D/E: Received autologous hematopoietic stem cell transplantation within 3 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 ≥CTCAE grade 1 due to any previous treatment, excluding alopecia and fatigue;
- •Major surgical treatment, open biopsy, and significant traumatic injury received within 28 days before the start of study treatment.
- •Having active or uncontrolled primary autoimmune hemocytopenia, including autoimmune hemolytic anemia (AIHA), primary immune thrombocytopenia (ITP), etc.
- •Patients with evidence or history of bleeding constitution; Or any bleeding event (such as gastrointestinal bleeding) greater than or equal to CTCAE level 3 within 4 weeks before the first dose;
- •Subjects who had an arteriovenous thrombosis event within 6 months.
- •Subjects who had a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
- •Subjects with any severe and/or uncontrolled disease.
- •Within one weeks before the first dose, the subjects had received proprietary Chinese medicines with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions;
- •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 dose;
- •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
TQB3909 tablets+ TQB3702 tablets
Experimental
TQB3909 tablets combined with TQB3702 tablets, administered orally, 28 days as a treatment cycle.
干预措施: TQB3909 tablets (Drug)
TQB3909 tablets+ TQB3702 tablets
Experimental
TQB3909 tablets combined with TQB3702 tablets, administered orally, 28 days as a treatment cycle.
干预措施: TQB3702 tablets (Drug)
结局指标
主要结局
Dose limited toxicity (DLT)
时间窗: Baseline up to 104 weeks
DLT will be defined as toxicities that meet pre-defined severity criteria (according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0), and assessed as having a suspected relationship to study drug.
Serious adverse events (SAE)
时间窗: Baseline up to 104 weeks
The occurrence of all serious adverse events (SAE).
Clinical laboratory abnormalities
时间窗: Baseline up to 104 weeks
Incidence of participants with abnormal clinical laboratory test results.
Adverse events (AE)
时间窗: Baseline up to 104 weeks
The occurrence of all adverse events (AE).
次要结局
- 2 years' OS rate(Baseline up to 104 weeks)
- Complete remission rate (CRR)/ Complete remission with incomplete bone marrow recovery rate (CRi)(Baseline up to 104 weeks)
- Duration of Response (DOR)(Baseline up to 104 weeks)
- Time to remission (TTR)(Baseline up to 104 weeks)
- Time to reach the maximum plasma concentration (Tmax)(Before the first dose of TQB3702 tablet and target dose of TQB3909 tablet. 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after the first target dose of TQB3909 tablet. The 4th /11th day before dosing with target dose of TQB3909 tablet.)
- Progression Free Survival (PFS)(Baseline up to 104 weeks)
- Objective Response Rate (ORR)(Baseline up to 104 weeks)
- Duration of complete remission / complete remission with incomplete bone marrow recovery(Baseline up to 104 weeks)
- Time to complete remission(Baseline up to 104 weeks)
- Overall Survival (OS)(Baseline up to 104 weeks)
- Undetectable measurable residual disease (U-MRD) ratio of peripheral blood and/or bone marrow(Baseline up to 104 weeks)
- Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)(Before the first dose of TQB3702 tablet and target dose of TQB3909 tablet. 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after the first target dose of TQB3909 tablet. The 4th /11th day before dosing with target dose of TQB3909 tablet.)
- Minimum steady-state plasma drug concentration during a dosage interval (Css-min)(Before the first dose of TQB3702 tablet and target dose of TQB3909 tablet. 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after the first target dose of TQB3909 tablet. The 4th /11th day before dosing with target dose of TQB3909 tablet.)
- 2 years' PFS rate(Baseline up to 104 weeks)
研究者
研究点 (1)
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