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Clinical Trials associated with Recombinant human anti-PD-1 monoclonal antibody(Shanghai Yunyi Health Technology Development Co Ltd)A Phase Ib/II Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor
This is a Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 and PE0105 Injection in Treatment of Patients with Advanced Solid Tumor.
一项评估PE0116联合PE0105注射液在晚期实体瘤患者中的耐受性、安全性和药代动力学特性以及初步有效性的Ib/II期临床研究
[Translation] A Phase Ib/II clinical study to evaluate the tolerability, safety, pharmacokinetic properties and preliminary efficacy of PE0116 combined with PE0105 injection in patients with advanced solid tumors
主要目的
(1) 评价PE0116联合PE0105在晚期实体瘤患者的安全性和耐受性。
(2) 探索PE0116联合PE0105的最大耐受剂量(Maximal Tolerated Dose,MTD),确定2期推荐剂量(Recommended Phase 2 Dose,RP2D)。
(3) 评价PE0116联合PE0105在晚期实体瘤患者中的有效性。
[Translation] Main objectives
(1) To evaluate the safety and tolerability of PE0116 combined with PE0105 in patients with advanced solid tumors.
(2) To explore the maximum tolerated dose (MTD) of PE0116 combined with PE0105 and determine the recommended phase 2 dose (RP2D).
(3) To evaluate the efficacy of PE0116 combined with PE0105 in patients with advanced solid tumors.
/ Not yet recruitingPhase 1/2 A Phase Ib/II Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor
This study is a one-arm, open, multicenter phase 1b/2 clinical trial of PE0116combined with PE0105 in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.PE0105 is administered as a fixed-dose intravenous injection(3mg/kg Q3w).
100 Clinical Results associated with Recombinant human anti-PD-1 monoclonal antibody(Shanghai Yunyi Health Technology Development Co Ltd)
100 Translational Medicine associated with Recombinant human anti-PD-1 monoclonal antibody(Shanghai Yunyi Health Technology Development Co Ltd)
100 Patents (Medical) associated with Recombinant human anti-PD-1 monoclonal antibody(Shanghai Yunyi Health Technology Development Co Ltd)
100 Deals associated with Recombinant human anti-PD-1 monoclonal antibody(Shanghai Yunyi Health Technology Development Co Ltd)