评估Pelareorep联合紫杉醇注射液用于晚期或转移性乳腺癌中国患者的安全性、耐受性和Pelareorep体内过程的多中心、单臂、开放I期临床试验
[Translation] A multicenter, single-arm, open-label phase I clinical trial evaluating the safety, tolerability and in vivo process of Pelareorep combined with paclitaxel injection in Chinese patients with advanced or metastatic breast cancer
主要目的:评价Pelareorep联合紫杉醇注射液用于晚期或转移性乳腺癌中国患者的安全性和耐受性,为后期临床试验制定给药方案提供依据。
次要目的:1) 评价Pelareorep在晚期或转移性乳腺癌中国患者中病毒载量、病毒脱落、病毒复制和中和抗体产生情况。
2) 初步评价Pelareorep联合紫杉醇注射液治疗晚期或转移性乳腺癌中国患者的有效性。
探索性目的:外周血中的生物标记物测定,包括基因表达分析、免疫细胞克隆性测定、基因组突变检测,以及它们与疗效之间的关系。
[Translation] Main purpose: To evaluate the safety and tolerability of Pelareorep combined with paclitaxel injection in Chinese patients with advanced or metastatic breast cancer, and to provide a basis for formulating dosing regimens for later clinical trials.
Secondary objectives: 1) To evaluate the viral load, viral shedding, viral replication and neutralizing antibody production of Pelareorep in Chinese patients with advanced or metastatic breast cancer.
2) Preliminary evaluation of the efficacy of Pelareorep combined with paclitaxel injection in the treatment of Chinese patients with advanced or metastatic breast cancer.
Exploratory purpose: Biomarker assays in peripheral blood, including gene expression analysis, immune cell clonality assay, genomic mutation detection, and their relationship to efficacy.
100 Clinical Results associated with SAFC Carlsbad, Inc.
0 Patents (Medical) associated with SAFC Carlsbad, Inc.
100 Deals associated with SAFC Carlsbad, Inc.
100 Translational Medicine associated with SAFC Carlsbad, Inc.