NCT05000684已完成1 期
A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab in Patients With Advanced Lung Cancer
Shanghai Junshi Bioscience Co., Ltd.2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2021年8月27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
- 已完成
- 发起方
- 入组人数
- 67
- 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/II study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of JS004 injection combined with toripalimab in patients with advanced lung cancer 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Within 2 years prior to enrollment, had other active neoplasm malignancies except for the study disease, but excluding neoplasm malignancies expected to be cured after treatment (including but not limited to thyroid cancer, carcinoma cervix in situ, basal or squamous cell skin carcinoma, or ductal carcinoma in situ after radical surgery after adequate treatment);
- •Patients previously treated with anti-BTLA or anti-HVEM antibodies;
- •Patients previously discontinued treatment due to PD-1/PD-L1 inhibitor toxicity;
- •Adverse reaction caused by prior treatment that has not recovered to CTCAE Grade 1 and below (except Grade 2 toxicity that is long-lasting, not recoverable, and does not increase safety risk);
- •Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
- •A large amount of hydrothorax or ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment;
- •Known history of Lung disorder: history of Interstitial pneumonia/drug-induced interstitial Pneumopathy or pneumonia, symptomatic Bronchospasm;
- •Active infection requiring systemic therapy;
- •A positive result for human immunodeficiency virus (HIV) antibody test;
- •Known active tuberculosis (TB). For patients with suspicion of active TB should perform the test of chest X-ray, sputum, clinical signs and symptoms to exclude；
- •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 240 mg was administered every 3 weeks as planned
Experimental
干预措施: JS004 in combination with toripalimab (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
- PFS(2 years)
- Cmax(2 years)
- DCR(2 years)
- OS(2 years)
- DOR(2 years)
- Tmax(2 years)
- Kel(2 years)
- Rac(2 years)
- AUC0-t(2 years)
- AUC0-inf(2 years)
- t1/2(2 years)
- CL/F(2 years)
- Vd/F(2 years)
研究者
研究点 (2)
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