重组人源化抗BTLA单克隆抗体(JS004)在晚期头颈癌患者的I/II期临床研究
[Translation] Phase I/II clinical study of recombinant humanized anti-BTLA monoclonal antibody (JS004) in patients with advanced head and neck cancer
I期:评估JS004注射液单药及联合特瑞普利单抗不同剂量水平治疗复发或转移性HNC的安全性和耐受性。 II期:依据实体瘤疗效评价指标1.1版(RECIST 1.1)评估的客观缓解率(ORR),评估JS004注射液单药及联合特瑞普利单抗治疗复发或转移性HNC的有效性。
[Translation] Phase I: Evaluate the safety and tolerability of JS004 injection alone and in combination with toripalimab at different dose levels in the treatment of recurrent or metastatic HNC. Phase II: Evaluate the effectiveness of JS004 injection alone and in combination with toripalimab in the treatment of recurrent or metastatic HNC based on the objective response rate (ORR) assessed by RECIST 1.1.
特瑞普利单抗联合贝伐珠单抗对比索拉非尼一线治疗晚期肝细胞癌的安全性和有效性的随机、开放、多中心III期研究
[Translation] A randomized, open-label, multicenter phase III study on the safety and efficacy of toripalimab combined with bevacizumab versus sorafenib as first-line treatment for advanced hepatocellular carcinoma
比较特瑞普利单抗联合贝伐珠单抗与索拉非尼一线治疗晚期肝细胞癌的总生存期(OS) 及由独立影像评审委员会根据RECIST v1.1标准评估的无进展生存期(PFS)。
[Translation] To compare the overall survival (OS) and progression-free survival (PFS) assessed by an independent imaging review committee according to RECIST v1.1 criteria between toripalimab plus bevacizumab and sorafenib as first-line treatment for advanced hepatocellular carcinoma.
重组人源化抗PD-L1单克隆抗体注射液用于晚期实体瘤患者的安全性、耐受性、药代动力学和药效学临床研究
[Translation] Clinical study on the safety, tolerability, pharmacokinetics and pharmacodynamics of recombinant humanized anti-PD-L1 monoclonal antibody injection in patients with advanced solid tumors
评估重组人源化抗PD-L1单克隆抗体(JS003)在经治的晚期或复发性实体瘤受试者中的安全性、耐受性和剂量限制性毒性(DLT)。
[Translation] To evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of a recombinant humanized anti-PD-L1 monoclonal antibody (JS003) in subjects with previously treated advanced or recurrent solid tumors.
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