5
项与 重组人源化抗VEGF单克隆抗体 (浙江特瑞思) 相关的临床试验A Phase 3, Multicenter, Randomized and Double-blind Study Assessing the Interchangeability Between TRS003 and China-approved Bevacizumab® (Also Called China-approved Avastin) For First-Line Treatment of Patients With Metastatic Colorectal Cancer (CRC)
This is a Phase 3, multicenter, randomized and double-blind study assessing the interchangeability between TRS003 and China-approved Bevacizumab® (also called China-approved Avastin) for first-line treatment of patients with metastatic Colorectal Cancer (CRC), approximately 126 patients will be enrolled in this study. Patients who sign the informed consent, meet the eligibility criteria and are confirmed as non-progressors after lead-in treatment period with Bevacizumab® in combination with modified FOLFOX6 chemotherapy for 6 cycles, will be randomized (1:1) to either the non-switching arm and receive Bevacizumab® + modified FOLFOX6 for all subsequent cycles or to the switching arm and receive TRS003 alternating with Bevacizumab® in combination with mFOLFOX6 until disease progression or intolerability.
评估TRS003 与中国许可的贝伐珠单抗®分别联合紫杉醇-卡铂治疗晚期非鳞非小细胞肺癌(NSCLC)受试者的有效性及安全性一致性的多中心、随机、双盲、III 期研究
主要目的:证明TRS003与紫杉醇-卡铂联合用药在晚期非鳞非小细胞肺癌受试者中,在第19周时经研究者评估的客观缓解率(ORR)(根据RECIST1.1标准)与中国许可的贝伐珠单抗®类似。
次要目的:1、评估TRS003和中国许可的贝伐珠单抗®分别联合紫杉醇-卡铂的缓解持续时间(DOR),无进展生存期(PFS)及总生存期(OS)。2、评估TRS003联合紫杉醇-卡铂和中国许可的贝伐珠单抗®联合紫杉醇-卡铂用药的安全性。3、评估TRS003和中国许可的贝伐珠单抗®的药代动力学(PK)。4、评估TRS003和中国许可的贝伐珠单抗®的免疫原性
A Phase 3, Multicenter, Randomized and Double-Blind Study to Assess the Similarity in Efficacy and Safety Between TRS003 and China-approved Bevacizumab in Subjects With Advanced Nonsquamous NSCLC
This is a double-blind Phase 3 clinical trial evaluating the efficacy and safety of TRS003 and paclitaxel-carboplatin versus China-approved bevacizumab and paclitaxel-carboplatin in patients with unresectable, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC). Approximately 608 patients will be enrolled in this study from America, Europe, and Asia. Patients who sign the informed consent and meet the inclusion criteria, will be randomized (1:1) to receive either TRS003 in combination with paclitaxel and carboplatin or China-approved bevacizumab in combination with paclitaxel and carboplatin for 4 to 6 cycles.
100 项与 重组人源化抗VEGF单克隆抗体 (浙江特瑞思) 相关的临床结果
100 项与 重组人源化抗VEGF单克隆抗体 (浙江特瑞思) 相关的转化医学
100 项与 重组人源化抗VEGF单克隆抗体 (浙江特瑞思) 相关的专利(医药)
100 项与 重组人源化抗VEGF单克隆抗体 (浙江特瑞思) 相关的药物交易