A MulticenterOpen LableDose Escalat Tion and Dose Expansion Clinical Study to Evaluate the Safety, Tolerance and Ini Itial Effectiveness of WTX212A Injection in Patients with Unresectable or Metasta Atic Advanced Solid Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- incidence of severe adverse events (SAE)
研究概览
简要总结
This trial is a multi-center, open-label investigator-initiated clinical study (IIT) to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid tumors who failed in previous systematic therapy.
The study was divided into two phases: dose escalation and dose expansion
详细描述
The study was divided into two phases: dose escalation and dose expansion Detailed Description: This trial is a multi-center, open-label investigator-initiated clinical study(llT)to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid tumors who failed in previous systematic therapy.
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
- •Must signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures;
- •Aged 18 to 75 years old (including threshold);
- •Histopathology diagnosed unresectable or metastatic solid tumors who have failed systemic treatment or have no effective standard treatment, or who are unwilling to accept standard treatment or are not suitable for standard treatment;
- •Expected life ≥ 3 months；
- •Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration;
- •Women of childbearing age must have a negative pregnancy testing results within ≤ 7 days before the first trial drug administration.
排除标准
- •Other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases,
- •Pleural and ascitic fluids with clinical symptoms and the need for repeated drainage;
- •Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia;
- •History of adverse events related to the use of IO drugs that require permanent cessation of IO treatment;
- •Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years.
- •Symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment;
- •Hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases;
- •Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment;
研究组 & 干预措施
WTX212A
WTX212A infusion once every 21 days
干预措施: WTX212A (Drug)
结局指标
主要结局
incidence of severe adverse events (SAE)
时间窗: through study completion, an average of 1 year
The incidence of SAE during the treatment of WTX212A injection
incidence of adverse events
时间窗: through study completion, an average of 1 year
The incidence of Adverse Events during the treatment of WTX212A injection
incidence of treatment related adverse events (TRAE)
时间窗: through study completion, an average of 1 year
The incidence of TRAE during the treatment of WTX212A injection
次要结局
- Cmin,ss(through study completion, an average of 1 months)
- Cmax,ss(through study completion, an average of 1 months)
- AUC（0-τ）ss.(through study completion, an average of 1 months)
- Tmax(through study completion, an average of 1 months)
- AUC0-t(through study completion, an average of 1 months)
- Tmax,ss(through study completion, an average of 1 months)
- the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells(through study completion, an average of 1 year)
- Cmax(through study completion, an average of 1 months)
- t1/2(through study completion, an average of 1 months)
- CL(through study completion, an average of 1 months)
- Objecive Response Rate (ORR)(through study completion, an average of 4 months)
- Anti-drug antibody (ADA)(through study completion, an average of 1 year)
研究者
TingBo Liang
Professor
Zhejiang University