NCT05110807Unknown1 期
Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3617 Capsule in Patients With Advanced Malignant Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
TQB3617 is a bromodomain and extra-terminal (BET) inhibitor that can competitively bind to bromodomains (BRDs) with Acetylated lysine(Kac) and block or partially block the role of KAc in subsequent gene transcription and regulation of chromatin structure, thereby playing an anti-tumor role.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged: ≥18 years old.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Life expectancy ≥ 3 months.
- •Patients with advanced malignancy tumor who have failed standard treatment or are unable to receive standard treatment or have no effective treatment.
- •Female and male subjects should agree to use an adequate method of contraception starting with signing informed consent form (ICF) through 180 days after the last dose of study. The women of reproductive age who blood/urine results were positivetherapy before the first study drug is administered within less than 7 days.
排除标准
- •Patients has had or is currently having other malignant tumors within 3 years.
- •Patients have multiple factors that affect their oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction).
- •The patient had unmitigated toxic reactions due to any prior treatment.
- •Patients underwent major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to the start of study treatment.
- •Patients have long - term unhealed wounds or fractures.
- •Patients were taking Cytochrome P450 3A4, Cytochrome P450 3A5, Cytochrome P450 2A6, Cytochrome P450 2D6 (CYP3A4, CYP3A5, CYP2A6,CYP2D6) inhibitors or inducers before oral medication.
- •Patients who, in the investigator's judgment, have a comorbidity that seriously endangers patient safety or interferes with study completion, or who are considered unsuitable for inclusion for other reasons.
研究组 & 干预措施
TQB3617
Experimental
0.1mg, once daily, was used as the initial dose, and the medication stage was divided into single administration and continuous administration stages. The single administration was given once, and the continuous administration stage was entered 7 days after drug withdrawal. The drug was administered continuously until the disease progressed.
干预措施: TQB3617 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Baseline up to 48 weeks
The highest dose of a drug or treatment that does not cause unacceptable side effects.
Adverse events (AEs) and serious adverse events (SAEs)
时间窗: Baseline up to 48 weeks
The occurrence of all AEs and SAEs
次要结局
- Minimum steady-state plasma drug concentration during a dosage interval （Css-min）(Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.)
- Concentration at the end of the dosing interval AUCtau,ss(Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.)
- Overall response rate (ORR)(up to 96 weeks)
- Duration of Response (DOR)(up to 96 weeks)
- Time to reach maximum (peak) plasma concentration following drug administration（Tmax）(Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.)
- Progress Free Survival（PFS）(up to 96 weeks)
- Maximum (peak) plasma drug concentration （Cmax）(Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.)
- Maximum (peak) steady-state plasma drug concentration during a dosage interval （Cmax,ss）(Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.)
- Disease control rate（DCR）(up to 96 weeks)
- Overall Survival（OS）(assessed up to 100 months)
- Elimination half-life (to be used in one-or non- compartmental model) （t1/2）(Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours, after oral administration of a single drug delivery.)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
1 期
A Clinical Study of TQB3107 Tablets in Patients With Malignant TumorsAdvanced CancersNCT06413953Chia Tai Tianqing Pharmaceutical Group Co., Ltd.140
已完成
1 期
Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric CancerSolid Tumor, ChildhoodBrain Tumor, PediatricLymphomaNCT03936465Dana-Farber Cancer Institute41
Unknown
1 期
A Clinical Trial of TQB3909 Tablets in Subjects With Advanced Malignant TumorsAdvanced Malignant TumorNCT04975204Chia Tai Tianqing Pharmaceutical Group Co., Ltd.126
已完成
1 期
Safety,PK/PD, Food Effect Study of Orally Administered HM71224 in Healthy Adult Male VolunteersRheumatoid ArthritisNCT01765478Hanmi Pharmaceutical Company Limited62
已完成
1 期
Safety Study of BTK Inhibitor, DTRMWXHS-12, Used Singly or in Combination, in CLL and B-cell LymphomasB-Cell LymphomaChronic Lymphocytic LeukemiaNCT02900716Zhejiang DTRM Biopharma48