A Phase I/IIa, Open-label, Dose-Escalation and Dose Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TJ107 in Chinese Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Serious adverse events
研究概览
简要总结
This is a two-part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of TJ107 in Chinese patients with advanced solid tumors. Approximately a total of 36 ~ 60 patients will be enrolled into the dose escalation cohorts (Part A), and expansion cohorts (Part B).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged at least 18 years old;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~2;
- •Patients must have histological or cytological confirmation of advanced solid tumors that is refractory to standard therapy or for which there is no standard available therapy;
- •Predicted life expectancy ≥3 months;
- •Patients must have adequate organ and marrow function;
- •Patients at reproductive age should take adequate contraceptive measures while on study drug and for 6 months following the last dose of study drug.
- •Patients should have the ability and willingness to comply with the study and follow up. And patients must be able to provide written informed consent.
排除标准
- •Patients who have experienced a Grade 3 or higher toxicity related to prior immunotherapy.
- •Patients who are still receive anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or other clinical trials from 4 weeks prior to the first dose, or patients who have not recovered from previous toxicity to level
- •Women who are pregnant or breast feeding
- •Patients who are drug-dependent or have a history of substance abuse or psychonosema history.
- •Have been vaccinated within 4 weeks of study dosing, with the exception of licensed intranasal or intramuscular influenza vaccine during study
- •Prior allogeneic bone marrow transplantation or prior solid organ transplantation
- •Positive laboratory test for HBsAg with HBV DNA ≥ 100 IU/mL, or positive laboratory test for HCV.
- •Prior treatment with immune checkpoint inhibitors, immunomodulatory mAbs, and/or mAb-derived therapies is allowed provided that at least 3 months or 5 half-lives of the drug, whichever is longer, have elapsed from the last dose.
- •Uncontrolled concurrent illness.
- •Major surgery procedure (excluding diagnostic surgery) within 4 weeks of the first dose of study drug.
- •Patients with a history of treated CNS metastases.
- •Other psychiatric illness/social situations that would limit compliance with the study requirements decided by the investigator.
研究组 & 干预措施
TJ107
Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period
干预措施: TJ107 (Drug)
结局指标
主要结局
Serious adverse events
时间窗: through study completion, an average of 1 year
Safety and tolerability of TJ107. Incidence of serious adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events(CI CTCAE 5.0)
Dose Limiting Toxicities
时间窗: 28days after first dose
Safety and tolerability of TJ107. Incidence of dose-limiting toxicities (DLTs)
Adverse events
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Safety and tolerability of TJ107. Incidence of adverse events
次要结局
- Maximum effective dose(through study completion, an average of 1 year)
- Maximum tolerated dose(through study completion, an average of 1 year)
- Recommended phase II dose(through study completion, an average of 1 year)