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A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment

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研究单位: [1]Zai Lab (Shanghai) Co., Ltd. [2]Beijing Cancer Hospital,Beijing,Beijing,China [3]Sun Yat-Sen University Cancer Center,Guangzhou,Guangdong,China [4]Henan Cancer Hospital,Zhengzhou,Henan,China,450000 [5]Henan Cancer Hospital,Zhengzhou,Henan,China [6]Hubei Cancer Hospital,Wuhan,Hubei,China [7]Liaoning Cancer hospital,Shenyang,Liaoning,China [8]First Affiliated Hospital of Xi'an Jiaotong University,Xi''an,Shaanxi,China [9]Obstetrics & Gynecology Hospital of Fudan University,Shanghai,Shanghai,China [10]Sichuan Cancer Hospital,Chengdu,Sichuan,China [11]TianJin Medical University General Hospital,Tianjin,Tianjin,China [12]The First Affiliated Hospital Zhejiang University School Of Medicine,Hangzhou,Zhejiang,China [13]Beijing Cancer Hospital,Beijing,China [14]Sun Yat-Sen University Cancer Center,Guangzhou,China [15]The Affiliated Tumor Hospital of Harbin Medical University,Ha''erbin,China [16]The Chinese University of Hong Kong, Prince of Wales Hospital,Hong Kong,China [17]The University of Hong Kong, Queen Mary Hospital,Hong Kong,China [18]Taizhou Hospital of Zhejiang Province,Taizhou,China [19]Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology,Wuhan,China [20]Sir Run Shaw Hospital, School Of Medicine ,Zhejiang University,Zhejiang,China

研究目的:
This is a a Multicenter, Open-label, Single-arm, Phase Ib Dose Escalation and Multi-cohort Expansion Clinical Study to Assess the Safety and Antitumor Activity of Niraparib in Combination with MGD013 in Patients with Advanced or Metastatic Solid Tumor Who Failed Prior Treatment. This study consists of dose escalation part and dose expansion part.'3+3'design will be adopted in the dose escalation part in subjects with advanced or metastatic gastric cancer who failed prior treatment. The dose of niraparib will be fixed and determined based on baseline weight and platelet count of subjects. Dose expansion part will be expanded at the specified dose level to further assess the safety and preliminary antitumor activity.

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