NCT07291050尚未招募1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3217 Tablets in Subjects With Advanced Malignant Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
This is the first-in-human clinical study of TQB3217, aiming to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB3217 in advanced solid tumors, and to preliminarily explore its efficacy in solid tumors.
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
- •Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
- •Gender is not restricted; Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; expected survival period ≥ 3 months;
- •Patients with histologically or cytologically confirmed advanced malignant solid tumors that have failed standard treatment (disease progression or intolerance) or for which there is no standard treatment plan;
- •The main organs function well;
- •Women of childbearing age should take effective contraceptive measures during the study and within 6 months after the end of the study; serum or urine pregnancy test must be negative within 7 days before enrollment, and they must be non-lactating subjects; men must agree to take effective contraceptive measures during the study and within 6 months after the end of the study.
排除标准
- •History of other malignant tumors within 3 years prior to the first administration of the study drug;
- •Has multiple factors affecting oral medication;
- •Unalleviated toxicity ≥ grade 1 above CTCAE v5.0 due to any previous therapy, excluding hair loss;
- •Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study, or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period;
- •Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism;
- •Patients who have epilepsy and need treatment or have a history of epileptic seizures, consciousness disorders or unexplained coma within the last 12 months;
- •Have a history of psychotropic drug abuse and can not quit or have mental disorders;
- •Subjects with any severe and / or uncontrolled disease;
- •Has known symptomatic central nervous system metastases and/or cancerous meningitis;
- •Presence of massive serous pleural/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage.
- •Has participated in other clinical trials within 4 weeks before first dose;
- •Receipt of chemotherapy or immunotherapy within 4 weeks before the first administration;, Receipt of radiotherapy or small molecule targeted drugs within 2 weeks, or are still within 5 half-lives of the drugs;
- •Receipt of Chinese patent medicines explicitly indicated for anti-tumor use in their drug labels approved by National Medical Products Administration (NMPA) within 2 weeks prior to the first administration;
- •According to the judgement of the investigators, Subjects who are at risk of active bleeding during the trial period.
研究组 & 干预措施
TQB3217Tablets
Experimental
TQB3217 Tablets: Administer once daily, recommended to be taken orally on an empty stomach in the morning at a fixed time, continuously, with each 21-day period as one treatment cycle.
干预措施: TQB3217Tablets (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 21 days)
DLT refers to occurrence of drug-related adverse events within the first treatment cycle after subjects receive single-dose or multiple-dose treatment, 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 21 days)
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Recommended Phase II Dose (RP2D)
时间窗: Baseline up to 24 months
DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3217 tablets in adult patients with advanced malignant cancer.
次要结局
- Numbers of participant with Adverse events (AEs) and serious adverse events (SAEs)(30 days after the last administration)
- Time to Reach the Maximum Plasma Concentration (Tmax)(Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle))
- Peak concentration (Cmax)(Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle))
- Half-life (t1/2)(Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle))
- Area under the concentration-time curve (AUC [0-infinity](Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle))
- Area under the concentration-time curve (AUC [0-t](Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle))
- Apparent clearance (CL/F)(Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle))
- Apparent Volume of Distribution during the Terminal Phase(Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle))
- Objective Response Rate (ORR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Overall Survival (OS)(From start of study treatment up to die ，estimated at two years)
研究者
研究点 (1)
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