NCT07715747尚未招募1 期
Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
TJ Biopharma Co., Ltd.1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2026年8月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Incidence,type,severity and correlation with study treament of AEs
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and tolerability of TJ037130 in participants with advanced or metastatic solid tumors, and to determine the Potential Optimal Biological Dose (POBD) of TJ037130 for subsequent investigations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Males or females aged 18 years or older;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Voluntarily enroll in the study and be able to comply with scheduled visits, treatment schedules, laboratory tests and other study procedures;
- •Participants with histologically and/or cytologically confirmed recurrent or metastatic advanced malignant tumors for whom no standard therapy with clinical benefit is available, or who are ineligible for existing standard treatment regimens. Claudin 6 (CLDN6) positive expression confirmed by immunohistochemistry (IHC) ;
- •Agree to provide archived tumor tissue or fresh biopsy tumor samples (not mandatory during the dose escalation phase);
- •Have at least one evaluable tumor lesion per RECIST Version 1.1 (dose escalation phase); have at least one measurable tumor lesion per RECIST Version 1.1 (dose expansion phase);
- •All acute adverse events resulting from prior anticancer therapies have resolved to Grade ≤ 1 or baseline per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (excluding toxicities judged by the Investigator to pose no safety risk, such as alopecia, peripheral neurotoxicity, hypothyroidism stabilized with hormone replacement therapy, etc.);
- •Be deemed an appropriate candidate for this clinical trial by the Investigator with an expected survival of ≥ 12 weeks;
- •Demonstrate adequate organ function within 7 days prior to the first dose of study drug;
- •Male and female participants of childbearing potential must agree to use two forms of effective contraception throughout the study period and for 6 months after the last dose of TJ
- •In addition, female participants of childbearing potential must have a negative serum or urine pregnancy test.
排除标准
- •Prior exposure to CLDN6-targeted therapy;
- •Prior exposure to 4-1BB agonists;
- •Received PD-1/PD-L1 therapy or other immune checkpoint inhibitors/agonists within 28 days prior to the first dose of study drug;
- •History of a second malignancy within the past 3 years, except cutaneous squamous cell carcinoma, cutaneous basal cell carcinoma, or carcinoma in situ of the cervix;
结局指标
主要结局
Incidence,type,severity and correlation with study treament of AEs
时间窗: Up to 90 days post last dose
次要结局
- Pharmacokinetic (PK) Parameters: AUCt(Up to 90 days post last dose)
- Pharmacokinetic (PK) Parameters: Cmax(Up to 90 days post last dose)
研究者
研究点 (1)
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