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Clinical Trials associated with Recombinant humanized monoclonal antibody MIL95(Beijing Mabworks)重组人源化单克隆抗体MIL95注射液治疗淋巴瘤及晚期恶性实体瘤的I期临床研究
[Translation] Phase I clinical study of recombinant humanized monoclonal antibody MIL95 injection in the treatment of lymphoma and advanced malignant solid tumors
Part A:MIL95预激剂量递增研究(多次给药):
观察MIL95在复发或难治淋巴瘤及晚期恶性实体瘤受试者中的剂量限制性毒性(DLT)和安全性,并确定后续研究MIL95的预激剂量。
Part B:MIL95维持剂量递增研究及扩展研究(多次给药):
观察MIL95在复发或难治淋巴瘤及晚期恶性实体瘤受试者中的DLT、最大耐受剂量(MTD)和安全性 ,并确定后续研究中MIL95的维持剂量。
[Translation] Part A: MIL95 pre-stimulation dose escalation study (multiple administrations):
Observe the dose-limiting toxicity (DLT) and safety of MIL95 in subjects with relapsed or refractory lymphoma and advanced malignant solid tumors, and determine the pre-stimulation dose of MIL95 in subsequent studies.
Part B: MIL95 maintenance dose escalation study and extension study (multiple administrations):
Observe the DLT, maximum tolerated dose (MTD) and safety of MIL95 in subjects with relapsed or refractory lymphoma and advanced malignant solid tumors, and determine the maintenance dose of MIL95 in subsequent studies.
A Phase I Clinical Study of Recombinant Humanized Monoclonal Antibody MIL95 Injection in the Treatment of Lymphomas and Advanced Malignant Solid Tumors
This study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design.
The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 3 dose cohorts (0.3mg/kg QW, 0.8mg/kg QW and 1mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.
Part B will have 5 dose cohorts(3mg/kg QW, 10mg/kg QW, 20mg/kg QW 30mg/kg QW and 45mg/kg QW). DLT observation period is 28 days. The subject number for each cohort in Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6.
A Phase I clinical study of recombinant humanized monoclonal antibody MIL95 injection in the treatment of lymphomas and advanced malignant solid tumors
100 Clinical Results associated with Recombinant humanized monoclonal antibody MIL95(Beijing Mabworks)
100 Translational Medicine associated with Recombinant humanized monoclonal antibody MIL95(Beijing Mabworks)
100 Patents (Medical) associated with Recombinant humanized monoclonal antibody MIL95(Beijing Mabworks)
100 Deals associated with Recombinant humanized monoclonal antibody MIL95(Beijing Mabworks)