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Clinical Trials associated with Recombinant humanized monoclonal antibody MIL93(Beijing Mabworks Biotech Co., Ltd.)评价重组人源化单克隆抗体MIL93 注射液治疗局部晚期或转移性实体瘤的耐受性、安全性、药代动力学和初步疗效的I/Ⅱ期临床研究
[Translation] A phase I/II clinical study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of recombinant humanized monoclonal antibody MIL93 injection in the treatment of locally advanced or metastatic solid tumors
第一阶段:评价 MIL93 单药在不可切除的局部晚期或转移性实体瘤患者中的耐受性和安全性, 并确定剂量限制性毒性(DLT) 和最大耐受剂量(MTD) 。
第二阶段:评价MIL93 联合化疗在不可切除的局部晚期或转移性胃和胃食管结合部腺癌、胰腺癌、胆道癌患者中的客观缓解率(ORR)。
第三阶段:评价MIL93 联合化疗或PD-1 单抗+/-化疗在不可切除的局部晚期或转移性胃和胃食管结合部腺癌患者中的客观缓解率(ORR)。
[Translation] Phase I: Evaluate the tolerability and safety of MIL93 monotherapy in patients with unresectable locally advanced or metastatic solid tumors, and determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).
Phase II: Evaluate the objective response rate (ORR) of MIL93 combined with chemotherapy in patients with unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma, pancreatic cancer, and biliary tract cancer.
Phase III: Evaluate the objective response rate (ORR) of MIL93 combined with chemotherapy or PD-1 monoclonal antibody +/- chemotherapy in patients with unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.
A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of MIL93 in Advanced or Metastatic Solid Tumors.
MIL93 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open label Phase I study to evaluate safety, tolerability, pharmacokinetics and efficacy of MIL93 in Advanced or Metastatic solid tumors.
100 Clinical Results associated with Recombinant humanized monoclonal antibody MIL93(Beijing Mabworks Biotech Co., Ltd.)
100 Translational Medicine associated with Recombinant humanized monoclonal antibody MIL93(Beijing Mabworks Biotech Co., Ltd.)
100 Patents (Medical) associated with Recombinant humanized monoclonal antibody MIL93(Beijing Mabworks Biotech Co., Ltd.)
100 Deals associated with Recombinant humanized monoclonal antibody MIL93(Beijing Mabworks Biotech Co., Ltd.)