A Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3912 Tablets in Subjects With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Dose Limiting Toxicities (DLT)
研究概览
简要总结
This is a study to evaluate the maximum tolerated dose (MTD), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters and antitumor effect of TQB3912 tablets in Chinese adult patients with advanced malignant neoplasm. The study was divided into phase Ia and phase Ib, Phase Ia: Dose escalation period, to evaluate the safety and tolerability of TQB3912 tablets, determine MTD; Phase Ib: Effectiveness exploration period, to expand the safe and effective dose group, and to 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
- •Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.
- •Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status score: 0-2; at least 3 months of expected survival period.
- •Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and/or cytology.
- •The function of main organs is normal.
- •Subjects need to adopt effective methods of contraception.
排除标准
- •Subjects with other malignancies currently or suffered within 3 years.
- •Subjects with Grade 1 or above unhealed toxicity reaction of Common Terminology Criteria for Adverse Events Version 5.0 due to previous antitumor treatment.
- •Subjects who have received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before first administration.
- •Subjects with long lasting wounds or fractures.
- •Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders.
- •Subjects with any severe and/or uncontrolled disease.
- •Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first administration.
- •Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration approved within 2 weeks before the first administration.
- •Subjects with pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
- •Subjects who have participated in other clinical studies within 4 weeks before the first administration.
- •According to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.
研究组 & 干预措施
TQB3912 tablets
TQB3912 tablets, 28 days as a treatment cycle.
干预措施: TQB3912 tablets (Drug)
结局指标
主要结局
Dose Limiting Toxicities (DLT)
时间窗: During the first 28 days.
Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug: grade III or above of non-hematological toxicity, grade III hematological toxicity, Neutropenia associated with fever.
Maximum tolerated dose (MTD)
时间窗: During the first 29 days.
MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).
Overall response rate (ORR)
时间窗: Up to 2 years
From the first drug treatment to the last drug treatment.
次要结局
- Time to reach maximum (peak) plasma concentration (Tmax)(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.)
- Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.)
- Incidence of adverse events (AEs)(From the time of informed consent signed to 90 days after the last dose)
- Incidence of serious adverse events (SAEs)(From the time of informed consent signed to 90 days after the last dose)
- Disease control rate (DCR)(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)
- Elimination half-life (t1/2) (to be used in one-or non- compartmental model)(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.)
- Overall survival (OS)(Up to 5 years)
- Duration of Response (DOR)(Up to 2 years)
- Maximum (peak) plasma drug concentration (Cmax)(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.)
- Area under the plasma concentration-time curve from time zero to time t (AUC0-t)(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.)