A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets
试验速览
- 阶段
- 1 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Adverse events (AE) and serious adverse events (SAE)
研究概览
简要总结
This is a study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3558 tablets in Chinese adult patients with advanced solid tumors .The study is divided into phase Ia and phase Ib. Phase Ia: dose escalation period, to evaluate the safety and tolerability of TQB3558 tablets, determine MTD; Phase Ib: effectiveness exploration period, to expand the safe and effective dose group, recommend appropriate dosage and method for subsequent clinical research.
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
- •Histologically or cytologically confirmed advanced malignant solid tumors, without conventional treatment methods or fail or relapse after treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
- •Has at least one measurable lesion (based on RECIST 1.1) or bone metastases.
- •Adequate organ system function.
- •Patients need to adopt effective methods of contraception.
- •Understood and signed an informed consent form.
排除标准
- •Has received TRK inhibitors.
- •Has participated in any other clinical trials, or used other anti-cancer drugs, or received major surgical operations within 4 weeks before first administration.
- •Has received local radiotherapy within 7 days or bone marrow radiotherapy within 4 weeks before the first administration.
- •Has other malignant tumors in 2 years, except for cured or locally curable cancers.
- •Has known spinal cord compression and cancerous meningitis.
- •Has interstitial lung disease, drug-induced interstitial lung disease, history of radiation lung disease requiring steroid therapy.
- •Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.
- •Obvious cardiovascular diseases.
- •Has a history of autoimmune disease, immunodeficiency.
- •Lactating women.
- •According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
研究组 & 干预措施
TQB3558 Tablets
TQB3558 tablets administered orally once. Then TQB3558 tablet administered orally, once daily in 28-day cycle after 4 days of first administration.
干预措施: TQB3558 (Drug)
结局指标
主要结局
Adverse events (AE) and serious adverse events (SAE)
时间窗: Baseline up to 28 days
The occurrence of all adverse events (AE) and serious adverse events (SAE).
Overall response rate (ORR)
时间窗: up to 96 weeks
Percentage of participants achieving complete response (CR) and partial response (PR).
Maximum tolerated dose (MTD)
时间窗: Baseline up to 28 days
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
次要结局
- AUC0-t(15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.)
- Tmax(15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.)
- Disease control rate（DCR）(up to 96 weeks)
- Progression-free survival (PFS)(up to 96 weeks)
- Duration of Response (DOR)(up to 96 weeks)
- Cmax(15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.)
- CL/f(15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.)