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Clinical Trials associated with Pertuzumab Biosimilar (CSPC Pharma)A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase Ⅲ Clinical Study to Compare the Efficacy and Safety of SYSA1901 vs Pertuzumab (Perjeta®) in the Neoadjuvant Therapy of HER2-Positive Breast Cancer
This is a phase Ⅲ, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of SYSA1901 + trastuzumab + docetaxel vs. Perjeta® + trastuzumab + docetaxel in the participants with early-stage or locally advanced HER2-positive and HR-negative breast cancer with a primary tumor > 2 cm.
比较SYSA1901单抗注射液/帕妥珠单抗(帕捷特®)联合曲妥珠单抗和多西他赛新辅助治疗早期或局部晚期HER2阳性乳腺癌患者的有效性和安全性的Ⅲ期临床研究
[Translation] A phase III clinical study comparing the efficacy and safety of SYSA1901 monoclonal antibody injection/Pertuzumab (Perjeta®) combined with trastuzumab and docetaxel in the neoadjuvant treatment of patients with early or locally advanced HER2-positive breast cancer
主要研究目的:
比较SYSA1901单抗/帕妥珠单抗(帕捷特®)联合曲妥珠单抗和多西他赛新辅助治疗早期或局部晚期HER2阳性乳腺癌患者的有效性。
次要研究目的:
比较SYSA1901单抗/帕妥珠单抗(帕捷特®)联合曲妥珠单抗和多西他赛新辅助治疗早期或局部晚期HER2阳性乳腺癌患者的安全性;
评价SYSA1901的药代动力学(PK)特征;
评价SYSA1901的免疫原性。
[Translation] Primary study objectives:
To compare the efficacy of SYSA1901/Pertuzumab (Perjeta®) combined with trastuzumab and docetaxel in the neoadjuvant treatment of patients with early or locally advanced HER2-positive breast cancer.
Secondary study objectives:
To compare the safety of SYSA1901/Pertuzumab (Perjeta®) combined with trastuzumab and docetaxel in the neoadjuvant treatment of patients with early or locally advanced HER2-positive breast cancer;
To evaluate the pharmacokinetic (PK) characteristics of SYSA1901;
To evaluate the immunogenicity of SYSA1901.
健康男性受试者单次静脉输注帕妥珠单抗注射液(SYSA1901注射液)和帕妥珠单抗注射液(帕捷特®/Perjeta®)的药代动力学比对研究
[Translation] Comparative study of the pharmacokinetic responses of single intravenous infusion of Pertuzumab Injection (SYSA1901 Injection) and Pertuzumab Injection (Perjeta®) in healthy male subjects
主要研究目的:考察生物类似药(SYSA1901注射液)的药代动力学特征,并以帕妥珠单抗注射液(商品名:帕捷特®/Perjeta®)为参照药,比较健康男性受试者静脉输注两制剂的主要药代动力学参数,评价两制剂的药代动力学相似性。
次要研究目的:比较生物类似药(SYSA1901注射液)和参照药帕妥珠单抗注射液(商品名:帕捷特®/Perjeta®)在健康男性受试者中单次静脉输注420 mg (14 mL)的安全性和免疫原性。
[Translation] The main purpose of the study is to investigate the pharmacokinetic characteristics of the biosimilar (SYSA1901 injection), and to compare the main pharmacokinetic parameters of the two preparations by intravenous infusion in healthy male subjects with Pertuzumab Injection (trade name: Perjeta®/Perjeta®) as the reference drug, and to evaluate the pharmacokinetic similarity of the two preparations.
Secondary purpose of the study is to compare the safety and immunogenicity of a single intravenous infusion of 420 mg (14 mL) of the biosimilar (SYSA1901 injection) and the reference drug Pertuzumab Injection (trade name: Perjeta®/Perjeta®) in healthy male subjects.
100 Clinical Results associated with Pertuzumab Biosimilar (CSPC Pharma)
100 Translational Medicine associated with Pertuzumab Biosimilar (CSPC Pharma)
100 Patents (Medical) associated with Pertuzumab Biosimilar (CSPC Pharma)
100 Deals associated with Pertuzumab Biosimilar (CSPC Pharma)