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Clinical Trials associated with Recombinant humanized anti-PD-1 monoclonal antibody(Anhui Anke Biotechnology (Group) Co., Ltd.)重组抗PD1人源化单克隆抗体注射液对晚期恶性肿瘤患者的安全性、耐受性、药代动力学及初步疗效的I/II期临床研究
[Translation] Phase I/II clinical study on the safety, tolerability, pharmacokinetics and preliminary efficacy of recombinant anti-PD1 humanized monoclonal antibody injection in patients with advanced malignant tumors
评价 PD1单抗注射液对晚期恶性肿瘤患者的安全性及耐受性; 评价单次及多次静脉输注 PD1 单抗注射液后药物代谢动力学(PK)参数; 评价单次及多次静脉输注 PD1 单抗注射液后外周血 T 细胞PD1 受体占有率(RO); 评价静脉输注PD1单抗注射液的免疫原性; 初步了解 PD1 单抗注射液免疫治疗晚期恶性肿瘤的活性(ORR、 DoR、 DCR、 PFS 等疗效指标)。
[Translation] To evaluate the safety and tolerability of PD1 monoclonal antibody injection in patients with advanced malignant tumors; To evaluate the pharmacokinetic (PK) parameters after single and multiple intravenous infusions of PD1 monoclonal antibody injection; To evaluate the PD1 receptor occupancy (RO) of peripheral blood T cells after single and multiple intravenous infusions of PD1 monoclonal antibody injection; To evaluate the immunogenicity of intravenous infusion of PD1 monoclonal antibody injection; To gain a preliminary understanding of the activity of PD1 monoclonal antibody injection in immunotherapy of advanced malignant tumors (ORR, DoR, DCR, PFS and other efficacy indicators).
100 Clinical Results associated with Recombinant humanized anti-PD-1 monoclonal antibody(Anhui Anke Biotechnology (Group) Co., Ltd.)
100 Translational Medicine associated with Recombinant humanized anti-PD-1 monoclonal antibody(Anhui Anke Biotechnology (Group) Co., Ltd.)
100 Patents (Medical) associated with Recombinant humanized anti-PD-1 monoclonal antibody(Anhui Anke Biotechnology (Group) Co., Ltd.)
100 Deals associated with Recombinant humanized anti-PD-1 monoclonal antibody(Anhui Anke Biotechnology (Group) Co., Ltd.)