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已发表论文
SG001（一种人源化抗 PD-1 抗体）治疗晚期实体瘤患者的 1b 期多中心研究
Authors Fang J , Jiang O , Li W, Lin J, Fang M, Li Q, Zhao W, Wang K, Shi H, Chen Z, Yu J, Xing X, Zhao M, Liu A, Wang W , Han Z, Xiang S, Zhang X, Li J, Zhou C
Received 12 June 2025
Accepted for publication 28 October 2025
Published 24 November 2025 Volume 2025:19 Pages 10423—10435
DOI https://doi.org/10.2147/DDDT.S546663
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Muzammal Hussain
Jian Fang,1 Ou Jiang,2 Wei Li,3 Jie Lin,4 Meiyu Fang,5 Qun Li,6 Weihong Zhao,7 Ke Wang,8 Huaqiu Shi,9 Zhendong Chen,10 Junyan Yu,11 Xiaojing Xing,12 Mingxuan Zhao,13 Anwen Liu,14 Wei Wang,15 Zhengquan Han,16 Silong Xiang,17 Xiao Zhang,17 Jin Li,6,* Caicun Zhou3,*
1Department of Thoracic Oncology, Peking University Cancer Hospital, Beijing, People’s Republic of China; 2Department of Cancer Center, Second People’s Hospital of Neijiang, Neijiang, People’s Republic of China; 3Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University Medical School Cancer Institute, Tongji University School of Medicine, Shanghai, People’s Republic of China; 4Department of Medical Oncology, The Second Affiliated Hospital of Kunming Medical University, Kunming, People’s Republic of China; 5Department of Chemotherapy, Chinese Academy of Sciences University Cancer Hospital (Zhejiang Cancer Hospital), Hangzhou, People’s Republic of China; 6Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, People’s Republic of China; 7Department of Medical Oncology, Chinese People’s Liberation Army General Hospital, Beijing, People’s Republic of China; 8Department of Gynaecological Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center of Cancer, Tianjin, People’s Republic of China; 9Department of Oncology, The First Affiliated Hospital of Gannan Medical University, Ganzhou, People’s Republic of China; 10Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, People’s Republic of China; 11Department of Oncology, Heping Hospital of Changzhi Medical College, Changzhi, People’s Republic of China; 12Department of Medical Oncology, Liaoning Cancer Hospital and Institute, Shenyang, People’s Republic of China; 13Research center for early clinical trials of Drugs (Vaccines), Anning First People’s Hospital Affiliated to Kunming University of Science and Technology, Anning, People’s Republic of China; 14Department of Oncology, Second Affiliated Hospital of Nanchang University, Nanchang, People’s Republic of China; 15Department of Medical Oncology, Hunan Cancer Hospital, Changsha, People’s Republic of China; 16Department of Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, People’s Republic of China; 17CSPC Zhongqi Pharmaceutical Technology Co., Ltd, Shijiazhuang, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Jin Li, Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, No. 1800, Yuntai Road, Shanghai, People’s Republic of China, Email lijin@csco.org.cn Caicun Zhou, Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University Medical School Cancer Institute, Tongji University School of Medicine, Shanghai, People’s Republic of China, Email caicunzhoudr@163.com
Background: SG001 is a humanized, IgG4 monoclonal antibody against human PD-1. This phase 1b study aimed to evaluate efficacy and safety of SG001 in advanced solid tumors.
Methods: Patients with previously treated solid tumors that are PD-L1-positive, and/or dMMR/MSI-H, and/or Epstein–Barr virus positive were enrolled in Cohort A, while patients with PD-L1-unselected malignant mesothelioma and PD-L1-unselected non-small cell lung cancer (NSCLC) were enrolled in Cohorts C and E, respectively. All patients in Cohorts A, C, and E received SG001 at a dose of 240mg every two weeks for 2 years or until disease progression, intolerable toxicities, or withdrawal of consent. The primary endpoint was the investigator-assessed overall response rate (ORR).
Results: A total of 87 patients were enrolled: 33 in Cohort A, 24 in Cohort C, and 30 in Cohort E. Investigator-assessed ORR was 39.4% in Cohort A, 12.5% in Cohort C, and 16.7% in Cohort E; corresponding median PFS values were 9.6, 4.1, and 4.0 months. The most common treatment-related adverse events (TRAEs) were increased alanine aminotransferase (13.8%), proteinuria (12.6%), rash (12.6%), and increased aspartate aminotransferase (10.3%). No TRAEs leading to death were reported.
Conclusion: SG001 demonstrated promising activity in patients with pretreated advanced solid tumors, especially those with PD-L1-positive NSCLC. The safety profile was well tolerated.
Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03852823.
Plain Language Summary: SG001 had an anti-tumor activity for pretreated advanced solid tumors.
SG001 demonstrated promising efficacy in PD-L1-positive NSCLC.
SG001 had well tolerated safety profiles.
Keywords: checkpoint inhibitor, programmed death-1 inhibitor, solid tumors, non-small cell lung cancer, mesothelioma
1Department of Thoracic Oncology, Peking University Cancer Hospital, Beijing, People’s Republic of China; 2Department of Cancer Center, Second People’s Hospital of Neijiang, Neijiang, People’s Republic of China; 3Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University Medical School Cancer Institute, Tongji University School of Medicine, Shanghai, People’s Republic of China; 4Department of Medical Oncology, The Second Affiliated Hospital of Kunming Medical University, Kunming, People’s Republic of China; 5Department of Chemotherapy, Chinese Academy of Sciences University Cancer Hospital (Zhejiang Cancer Hospital), Hangzhou, People’s Republic of China; 6Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, People’s Republic of China; 7Department of Medical Oncology, Chinese People’s Liberation Army General Hospital, Beijing, People’s Republic of China; 8Department of Gynaecological Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center of Cancer, Tianjin, People’s Republic of China; 9Department of Oncology, The First Affiliated Hospital of Gannan Medical University, Ganzhou, People’s Republic of China; 10Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, People’s Republic of China; 11Department of Oncology, Heping Hospital of Changzhi Medical College, Changzhi, People’s Republic of China; 12Department of Medical Oncology, Liaoning Cancer Hospital and Institute, Shenyang, People’s Republic of China; 13Research center for early clinical trials of Drugs (Vaccines), Anning First People’s Hospital Affiliated to Kunming University of Science and Technology, Anning, People’s Republic of China; 14Department of Oncology, Second Affiliated Hospital of Nanchang University, Nanchang, People’s Republic of China; 15Department of Medical Oncology, Hunan Cancer Hospital, Changsha, People’s Republic of China; 16Department of Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, People’s Republic of China; 17CSPC Zhongqi Pharmaceutical Technology Co., Ltd, Shijiazhuang, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Jin Li, Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, No. 1800, Yuntai Road, Shanghai, People’s Republic of China, Email lijin@csco.org.cn Caicun Zhou, Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University Medical School Cancer Institute, Tongji University School of Medicine, Shanghai, People’s Republic of China, Email caicunzhoudr@163.com
Background: SG001 is a humanized, IgG4 monoclonal antibody against human PD-1. This phase 1b study aimed to evaluate efficacy and safety of SG001 in advanced solid tumors.
Methods: Patients with previously treated solid tumors that are PD-L1-positive, and/or dMMR/MSI-H, and/or Epstein–Barr virus positive were enrolled in Cohort A, while patients with PD-L1-unselected malignant mesothelioma and PD-L1-unselected non-small cell lung cancer (NSCLC) were enrolled in Cohorts C and E, respectively. All patients in Cohorts A, C, and E received SG001 at a dose of 240mg every two weeks for 2 years or until disease progression, intolerable toxicities, or withdrawal of consent. The primary endpoint was the investigator-assessed overall response rate (ORR).
Results: A total of 87 patients were enrolled: 33 in Cohort A, 24 in Cohort C, and 30 in Cohort E. Investigator-assessed ORR was 39.4% in Cohort A, 12.5% in Cohort C, and 16.7% in Cohort E; corresponding median PFS values were 9.6, 4.1, and 4.0 months. The most common treatment-related adverse events (TRAEs) were increased alanine aminotransferase (13.8%), proteinuria (12.6%), rash (12.6%), and increased aspartate aminotransferase (10.3%). No TRAEs leading to death were reported.
Conclusion: SG001 demonstrated promising activity in patients with pretreated advanced solid tumors, especially those with PD-L1-positive NSCLC. The safety profile was well tolerated.
Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03852823.
Plain Language Summary: SG001 had an anti-tumor activity for pretreated advanced solid tumors.
SG001 demonstrated promising efficacy in PD-L1-positive NSCLC.
SG001 had well tolerated safety profiles.
Keywords: checkpoint inhibitor, programmed death-1 inhibitor, solid tumors, non-small cell lung cancer, mesothelioma