Phase I Clinical Study on the Safety, Pharmacokinetics and Antitumor Activity of SSGJ-612 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence and severity of Adverse Events (AEs)
研究概览
简要总结
This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSGJ-612 in patients with advanced malignant solid tumors expressing HER2.
详细描述
The clinical trial consists of two phases. In the dose escalation stage, the accelerated titration method combined with the traditional "3+3" design will be adopted, to evaluate the safety and dose-limiting toxicity (DLT), and to determine the maximum tolerated dose (MTD) or the maximum dose of administration (MAD). In the dose expansion phase, several safe and effective dose levels of SSGJ-612 will be expanded and further evaluated in larger groups of participants.
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
- •Voluntarily participate in this study, be willing to follow and complete all trial procedures, and sign the informed consent form;
- •Aged ≥18 and ≤75 years old at the time of signing the ICF, regardless of gender;
- •Expected survival ≥3 months;
- •Performance status (PS) score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale;
- •Patients with pathologically or cytologically confirmed locally advanced or metastatic malignant tumors who have failed standard treatment, are intolerant to standard treatment, or have no standard treatment available, and cannot undergo complete surgical resection or receive radical concurrent/sequential chemoradiotherapy;
- •Tumor tissue with HER2 expression;
- •At least one measurable tumor lesion assessed as the target lesion according to RECIST v1.1 criteria, and the lesion is suitable for repeated and accurate measurement.
排除标准
- •Presence of brainstem, meninges, or spinal cord metastasis, or spinal cord compression;
- •Presence of active central nervous system (CNS) metastatic lesions;
- •Individuals with clinical symptoms or requiring repeated drainage (once a month or more frequently) of pleural effusion, pericardial effusion, or ascites;
- •Primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) test;
- •Known active tuberculosis; known active syphilis infection;
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Use of any live vaccine or attenuated live vaccine within 4 weeks before the first dose, or plan to receive any live vaccine or attenuated live vaccine during the study;
- •Known severe allergic history to any component of the investigational drug, or history of severe allergic reaction to antibodies;
- •Pregnant or lactating women.
研究组 & 干预措施
SSGJ-612
In dose escalation phase, participants will receive one of the five increasing dose levels of SSGJ-612 respectively, intravenously (IV). During or after dose escalation, any dose levels that does not exceed the MTD can be expanded.
干预措施: SSGJ-612 (Drug)
结局指标
主要结局
Incidence and severity of Adverse Events (AEs)
时间窗: Through study completion, an average of 1 year
Adverse Events (AEs) refers to all adverse medical events that occur in patients after they receive the investigational drug and do not necessarily have a causal relationship with the investigational drug. AEs were evaluated according to CTCAE V5.0.
Incidence of DLT
时间窗: 14 days
Dose-Limiting Toxicity
次要结局
- ORR assessed by investigators per RECIST v1.1(Through study completion, an average of 1 year)
- DoR assessed by investigators per RECIST v1.1(Through study completion, an average of 1 year)
- DCR assessed by investigators per RECIST v1.1(Through study completion, an average of 1 year)
- TTR assessed by investigators per RECIST v1.1(Through study completion, an average of 1 year)
- PFS(Through study completion, an average of 1 year)
- OS(Through study completion, an average of 1 year)
- Cmax of SSGJ-612(Through study completion, an average of 1 year)
- Cmin of SSGJ-612(Through study completion, an average of 1 year)
- Tmax of SSGJ-612(Through study completion, an average of 1 year)
- T1/2 of SSGJ-612(Through study completion, an average of 1 year)
- AUC0-last(Through study completion, an average of 1 year)
- Incidence of ADA and Nab(Through study completion, an average of 1 year)
- The correlation between HER2 expression and efficacy(Through study completion, an average of 1 year)