NCT06413953招募中1 期
A Phase I Clinical Study of Tolerability and Pharmacokinetics of TQB3107 Tablets in Patients With Malignant 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
- 140
- 试验地点
- 13
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
TQB3107 is an target inhibitor that binds to target to induce apoptosis and inhibits the proliferation of a variety of tumor cells. This is a clinical study to evaluate the safety and tolerability of TQB3107 tablets in subjects with advanced malignancies, to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) (if any), and the recommended dose for Phase II (RP2D).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years ≤ age≤ 75 years (calculated from the date of signing the informed consent); Score 0~1 point, estimated survival ≥ 3 months；
- •Advanced malignant tumor；
- •The major organs are functioning well；
- •Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception throughout the study and for 6 months after the study ends;
- •Subjects voluntarily participated in this study, signing the informed consent form and demonstrating good compliance.
排除标准
- •Hematologic malignancy has or is suspected to involve the central nervous system, or primary central nervous system lymphoma;
- •Received any anti-cancer therapy such as major surgery, chemotherapy and/or radiotherapy, immunotherapy, or targeted therapy within 4 weeks prior to the first dose;
- •Combined with severe or not well-controlled diseases, which the investigator judges to be at greater risk of entering this study；
- •Those with a history of drug addiction or substance abuse；
- •According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.
研究组 & 干预措施
TQB3107 tablets
Experimental
Dosing regimen 1 (20/28): 28 days per cycle (4 weeks), the medication is administered once daily for 5 consecutive days per week, followed by a 2-day break. The initial dose is a single fasting dose of C0, with a subsequent 7-day observation period.
Dosing regimen 2 (12/28): every 28 days per cycle, with intermittent dosing.
干预措施: TQB3107 Tablets (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: At the end of Cycle 1 (each cycle is 28 days)
DLT refers to toxicities that are associated with the drug and occur from the first medication administration to the end of the first treatment cycle, as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity assessment criteria.
Maximum tolerated dose (MTD)
时间窗: At the end of Cycle 1 (each cycle is 28 days)
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Phase II Recommended Dose (RP2D)
时间窗: Baseline up to 24 months
The recommended dose, determined after initial dose escalation and toxicity assessment, it is used to further evaluate the efficacy and safety of the drug.
次要结局
- Elimination half-life (t1/2)(Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose)
- Time to Peak (Tmax)(Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose；Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose)
- Area under the plasma concentration-time curve (AUC0-last)(Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose)
- Progression-free survival (PFS)(Up to 2 years)
- Steady-state peak concentration (Css-max)(Day 1 of cycle 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose)
- Objective Response Rate (ORR)(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Peak Concentration (Cmax)(Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose)
- Overall Survival (OS)(Up to 2 years)
- Steady-state trough concentration (Css-min)(Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose)
- Elimination half-life (t1/2)(Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.)
- Time to Peak (Tmax)(Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.)
- Peak Concentration (Cmax)(Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.)
- Area under the plasma concentration-time curve (AUC0-last)(Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.)
- Steady-state peak concentration (Css-max)(Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.)
- Steady-state trough concentration (Css-min)(Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.)
- Objective Response Rate (ORR)(UP to 3 years)
- Disease Control Rate (DCR)(UP to 3 years)
- Duration of Response (DOR)(UP to 3 years)
- Progression-free survival (PFS)(UP to 3 years)
- Overall Survival (OS)(UP to 3 years)
研究者
研究点 (13)
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