NCT05427396终止1 期
A Phase I Clinical Study Evaluating the Safety, Tolerability,of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined Witht Oripalimab in Patients With Advanced Solid Tumors
Shanghai Junshi Bioscience Co., Ltd.2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2022年7月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
研究概览
简要总结
This is an open-label phase I study to evaluate the safety, tolerability, and initial efficacy of JS004 injection combined with Toripalimab Injection in patients with advanced solid tumors who have failed standard 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form voluntarily;
- •Patient (both sex) ≥ 18 and ≤70 years at the time of signing informed consent;
- •Expected survival ≥ 3 months;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Patients with advanced solid tumors confirmed histologically or cytologically
- •At least one measurable lesion as a target lesion (RECIST v1.1 criteria);
- •Agree to provide tumor tissue samples (provide fresh biopsy samples before treatment as far as possible;
- •The patient has good organ function as indicated by screening laboratory results
- •Males of reproductive potential or females of childbearing potential must use effective contraceptive methods (such as oral contraceptives, intrauterine device or barrier method combined with spermicide) during the trial and continue contraception for 6 months after the end of treatment;
- •Good compliance and cooperated with the follow-up.
排除标准
- •Any malignancy other than the disease under study within the past 5 years, except for malignancies that can be expected to be cured after treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated surgically with curative intent);
- •patients received systemic antitumor therapy (including chemotherapy, small-molecule targeted drug therapy, endocrine therapy, etc.) or local antitumor therapy within 4 weeks prior to 1st administration
- •Received immunotherapy (including antibody and cell therapy) within 4 weeks prior to 1st administration
- •Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
- •Central nervous system metastases and/or cancerous meningitis
- •Have or are suspected of having active autoimmune diseases, including but not limited to systemic lupus erythematosus rheumatoid arthritis inflammatory bowel disease autoimmune hepatitis
- •A large amount of hydrothorax or ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment;
- •Have serious cardiovascular and cerebrovascular diseases, such as poorly controlled hypertension (systolic blood pressure>140mmHg and/or diastolic pressure> 90mmHg) or pulmonary arterial hypertension; Unstable angina or had a myocardial infarction in the 6 months prior to study use and had coronary artery bypass grafting or stenting; Chronic heart failure with grade 2 heart function (NYHA); Degree above heart block; Left ventricular ejection fraction (LVEF)<50%; Cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurred within 6 months prior to medication
- •Pulmonary disease: interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm;
- •A positive result for human immunodeficiency virus (HIV) antibody test;
- •Known active tuberculosis (TB).
- •Live vaccine was administered within 4 weeks prior to 1st administration
- •Major surgical procedures (as defined by the investigator, e.g., open biopsy, severe trauma, etc.) within 4 weeks prior to 1st administration
- •Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders;
- •Pregnant or lactating woman;
- •Known to be allergic to JS004 or toripalimab and its components;
- •Other severe, acute or chronic medical or psychiatric disorders or laboratory abnormalities that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results.
研究组 & 干预措施
JS004 200 mg in combination with Toripalimab Injection 240 mg was administered every 3 weeks
Other
干预措施: JS004 (Drug)
JS004 200 mg in combination with Toripalimab Injection 240 mg was administered every 3 weeks
Other
干预措施: Toripalimab Injection (Drug)
结局指标
主要结局
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
时间窗: 2 years
Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests
次要结局
- DCR(2 years)
- PFS(2 years)
- OS(2 years)
- DOR(2 years)
- TTR(2 years)
- TTP(2 years)
- ORR(2 years)
研究者
研究点 (2)
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