NCT06188624招募中1 期
A Phase I Clinical Study of TQB2922 for Injection in Patients With Advanced Cancers
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.17 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 17
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers
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 voluntarily join this study, sign the informed consent form, and have good compliance；
- •Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months；
- •Histologically or cytologically diagnosed with advanced cancers;
- •Subjects with advanced malignancies who have failed standard therapy or lack effective treatment;
- •Major organs are functioning well;
- •Female and male subjects of childbearing potential should agree to practice contraception during the study and until 6 months after the completion of the study.
排除标准
- •Current concomitant or ever presented with other malignancies within 2 years prior to the first dose;
- •Unresolved toxicity of Grade 1 or above according to CTCAE due to any prior anti-tumor therapy;
- •Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;
- •Long-term unhealed wounds or fractures
- •Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;
- •A history of psychotropic drug abuse and cannot be abstained, or have a mental disorder;
- •Subjects with any severe and/or uncontrolled disease;
- •History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;
- •Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2922 for injection or its excipients;
- •According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.
研究组 & 干预措施
TQB2922 for injection
Experimental
TQB2922 for injection, 28 days as a treatment cycle
干预措施: TQB2922 for injection (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: During the first treatment cycle (28 days).
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Adverse events (AEs) rate
时间窗: From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.
The occurrence rate of all AEs during treatment
Dose limiting toxicity (DLT)
时间窗: During the first treatment cycle (28 days).
DLT is defined as toxicities that meet pre-defined severity criteria according to the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0 toxicity assessment criteria, and assessed as having a suspected relationship to study drug that occurred.
Adverse events (AEs) severity
时间窗: From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.
The severity of all AEs occured during treatment
次要结局
- Half-life (T1/2)(Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.)
- Apparent volume of distribution (Vz)(Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.)
- Minimum concentration (Cmin)(Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.)
- Progression-free survival (PFS)(Up to 2 years.)
- Objective response rate (ORR)(Up to 2 years.)
- Immunogenicity of TQB2922(From the time of informed consent to 90 days after the last dose.)
- The area under the curve (AUC)(Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.)
- Apparent plasma clearance (CL)(Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.)
- Duration of response (DOR)(Up to 2 years.)
研究者
研究点 (17)
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