NCT05213767Unknown1 期
Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2022年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. The purpose is to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB2916 injection in patients with advanced tumors, and to initially evaluate the antitumor efficacy of TQB2916 injection.
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
- •1 Subjects with advanced malignant tumors clearly diagnosed by pathology and / or cytology, lack of conventional effective treatment methods, failure or relapse after treatment.
- •2 18-75 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-1; at least 3 months expected survival period.
- •3 The function of main organs is normal.
- •4 Subjects must need to adopt effective methods of contraception.
- •5 Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
排除标准
- •1 Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved R0 resection without recurrence and metastasis. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)].
- •2 The toxicity of previous antitumor treatment is not recovered to ≤ grade 1 (Common Terminology Criteria for Adverse Events (CTCAE) 5.0).
- •3 Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before treatment.
- •4 Subjects had an arteriovenous thrombosis event within 6 months.
- •5 Subjects occurred Evans syndrome within 3 months.
- •6 History of drug abuse, alcohol or drug abuse or mental disorder.
- •7 Subjects who suffered from Active tuberculosis within 1 year.
- •8 The subjects had any history of bleeding or coagulopathy.
- •9 Cirrhosis, active hepatitis.
- •10 The subjects was diagnosed with renal failure and required hemodialysis or peritoneal dialysis.
- •11 History of immunodeficiency, including positive human immunodeficiency virus (HIV) test or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
- •12 Subjects who have epilepsy and require treatment.
- •13 Received the treatment of proprietary Chinese medicines with anti-tumor indications clearly stated in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks of starting treatment.
- •14 The symptoms of subjects with known central nervous system metastasis, spinal cord compression, meningeal metastasis, or leptomeningeal disease.
- •15 Vaccination history of live attenuated vaccine before 28 days of starting treatment, or planned vaccination of live attenuated vaccine during the study period.
- •16 History of severe allergy to macromolecule drugs or known components of TQB2916 injection.
- •17 Receiving any other investigational agent within 4 weeks before first dose.
- •18 According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subject or affect the completion of the study.
研究组 & 干预措施
TQB2916 injection
Experimental
2.5mg/ quaque die (QD) was used as the initial dose, 21 days as a treatment cycle. The drug is administered on the first day of each cycle until the disease progresses or the investigator judges that it is not suitable for subject to continue to take medicine.
干预措施: TQB2916 injection (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Baseline up to 52 weeks
To evaluate MTD of TQB2916 injection in patients with advanced solid tumors
Dose limited toxicity (DLT)
时间窗: Baseline up to 52 weeks
To evaluate DLT of TQB2916 injection in Chinese adult patients with advanced solid tumors
Recommended Phase II Dose (RP2D)
时间窗: Baseline up to 52 weeks
To evaluate RP2D of TQB2916 injection in Chinese adult patients with advanced solid tumors
次要结局
- Adverse events (AE) , serious adverse events (SAE) and treatment-related adverse events (TRAE)(Baseline up to 104 weeks)
- Tmax((-1 to 0 hour) (pre-dose), 0，1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.)
- Maximum (peak) plasma drug concentration (Cmax)((-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.)
- Elimination half-life (t1/2)((-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.)
- Area under the plasma concentration-time curve from time zero to time t (AUC0-t)((-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.)
- Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)((-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.)
- Concentration at the end of the dosing interval AUCtau,ss((-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.)
- Minimum steady-state plasma drug concentration during a dosage interval (Css-min)((-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.)
- Progress Free Survival (PFS)(up to 96 weeks)
- Disease control rate (DCR)(up to 96 weeks)
- Duration of Response (DOR)(up to 96 weeks)
- Overall survival (OS)(up to 96 weeks)
研究者
研究点 (1)
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