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A Clinical Study to Evaluate HLX10 Monotherapy for the Treatment of MSI-H or dMMR Solid Tumors That Failed to Respond to Standard Therapy

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研究单位: [1]Shanghai Henlius Biotech [2]Sichuan Cancer Hospital & Institute,Sichuan Cancer Center,School of Medicine,University of Electronic Science and Technology of China Chengdu,Sichuan,China,610041 [3]West China Hospital,Sichuan University Chengdu,Sichuan,China,610041 [4]Tianjin Medical University Cancer Institue and Hospital Tianjin,Tianjin,China,300060 [5]Yunnan Cancer Hospital/The Third Affiliated Hospital of Kunming Medical University/Yunnan Cancer Center Kunming,Yunnan,China,650118 [6]Zhejiang Cancer Hospital Hangzhou,Zhejiang,China,310022 [7]Taizhou first people's Hospital Taizhou,Zhejiang,China,318020 [8]The Fifth Affiliated Hospital,Sun Yat-sen University Zhuhai,Guangdong,China,519000 [9]The People's Hospital of Guangxi Zhuangzu Autonomous Region Nanning,Guangxi,China,530016 [10]Fourth Hospital of Hebei Medical University,Shijia Zhuang,Hebei,China,050011 [11]Harbin Medical University Cancer Hospital,Harbin,Heilongjiang,China,150040

研究目的:
It is a single-arm,open-label,multicenter,phase II clinical study to evaluate the clinical efficacy and safety of HLX10 monotherapy for the treatment of patients with unresectable or metastatic MSI-H or dMMR solid tumors who have progressed or intolerable after standard therapy.This study consists of three periods,screening period (28 days),treatment period and follow-up period (including safety follow-up,survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. The enrolled subjects will receive an intravenous infusion of HLX10 (3 mg/kg) once every 2 weeks until the loss of clinical benefit,death,intolerable toxicity,withdrawal of informed consent or other reasons as specified in the protocol,or up to the longest treatment duration-2 years (52 dosing periods) (whichever occurs earlier).

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