Phase I Clinical Study Evaluating the Tolerability and Pharmacokinetics of TQB2029 for Injection in Subjects With Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 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), dose limiting toxicity (DLT), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, and anti-tumor effects of TQB2029 for injection in Chinese adult subjects with multiple myeloma. The study is divided into Phase Ia and Ib, Phase Ia: dose escalation phase, to evaluate the safety and tolerability of TQB2029 for injection, and determining DLT and MTD; Phase Ib: Dose extension phase, to evaluate the effectiveness of TQB2029 for injection in subjects with multiple myeloma.
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 12 weeks expected survival period.
- •Multiple myeloma with diagnostic records and meeting the International Myeloma Working Group (IMWG) diagnostic criteria
- •There are measurable lesions present
- •The function of main organs is normal.
- •Subjects need to adopt effective methods of contraception.
排除标准
- •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 who received targeted therapy or immunotherapy within 3 weeks before the first medication
- •Subjects who is known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- •Subjects who has had or currently has other malignant tumors within the past 3 years prior to the first use of medication
- •Subjects who with unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTC AE) grade 1 caused by any previous treatment
- •Subjects who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication
- •Subjects who have experienced arterial/venous thrombotic event occurred within 6 months prior to the first administration
- •Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders;
- •Subjects with any severe and/or uncontrolled disease
- •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
TQB2029 injection
TQB2029 injection, 28 days as a treatment cycle.
干预措施: TQB2029 injection (Drug)
结局指标
主要结局
Dose Limiting Toxicities (DLT)
时间窗: During the first 28 days
DLT refers to any of the following events in the first administration of TQB2029 for injection to the end of the first treatment cycle (C1D28) that the investigator and the sponsor consider to be related to the treatment of TQB2029 for injection.
Maximum tolerated dose (MTD)
时间窗: Up to 18 months
After the experiment is completed, sequential regression is used to determine the maximum tolerated dose (MTD). Specifically, calculate the toxicity rate of each dose group and select the dose closest to the target toxicity rate as MTD.
Recommended Phase II Dose (RP2D)
时间窗: Up to 18 months
Determine RP2D based on target toxicity rates for each dose group
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
时间窗: Up to 18 months
Assessed by the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) v5.0.
次要结局
- Elimination half-life (to be used in one-or non- compartmental model) (t1/2)(The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.)
- Maximum (peak) plasma drug concentration (Cmax)(The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.)
- Area under the plasma concentration-time curve from time zero to time t (AUC0-t)(The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.)
- Apparent clearance rate (CL/F)(The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.)
- Volume of distribution(Vz/F)(The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.)
- Blood drug trough concentration (Cmin)(The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.)
- Exploring the correlation between changes in cytokine levels, lymphocyte subpopulation levels, and therapeutic efficacy(The first and second treatment cycle: 0, 2, 6, 24, 48, 72 hours after dosing on the first day, 0 hours on the 15th day;The first treatment cycle: 0 hours on the 8th day;0 hours on the 22th day;The third and fourth treatment cycle: 0 hours on the 1st day.)
- Immunogenicity analysis- positive anti drug antibodies (ADA)(The first, third, sixth, twelfth treatment cycle: 0 hours on the first day;and End of Treatment Visit (EOT))
- Overall response rate (ORR)(Up to 18 months)
- Very good partial response rate (VGPR)(Up to 18 months)
- Complete Response (CR)(Up to 18 months)
- Strict Complete Response (sCR) Rate(Up to 18 months)
- Negative rate of minimal residual disease (MRD)(Up to 18 months)
- Duration of remission (DOR)(Up to 18 months)
- Time to first remission (TTR)(Up to 18 months)
- Progression-free survival (PFS)(Up to 18 months)
- Overall survival (OS)(Up to 18 months)