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Scientific Publications

A Phase I Study of TST001, a High Affinity Humanized Anti-CLDN18.2 Monoclonal Antibody, in Combination with Capecitabine and Oxaliplatin (CAPOX) as the First Line Treatment of Advanced and Metastatic G/GEJ Cancer

05 Jun, 2022

Authors:

Jifang Gong1, Ning Li2, Weijian Guo3, Jian Zhang4, Hongli Li5, Fuyou Zhao6, Wei Li7, Meili Sun8, Zhenzhong Xia9, Yu Shen9, Jianming Wang9, Lingmin Lu9, Chuan Qi9, Xueming Qian9, Michael Shi9, Lin Shen1;

1Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China; 2Henan Cancer Hospital, Zhengzhou, China; 3Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; 4Phase I Clinical Trial Center, Fudan University Shanghai Cancer Center, Shanghai, China; 5Tianjin Medical University Cancer Institute and Hospital, Tianjin, China; 6The First Affiliated Hospital, Bengbu Medical College, Bengbu, China; 7The First Hospital of Jilin University, Jilin, China; 8Jinan Central Hospital Affiliated to Shandong University, Jinan, China; 9Suzhou Transcenta Therapeutics Co., Ltd

Background:

 TST001 is a recombinant humanized IgG1 antibody specifically against human Claudin18.2 (CLDN18.2) with high affinity and enhanced FcR engaging of NK cell.

 In vivo pharmacology of TST001 in gastric PDX tumor model with CLDN18.2 medium expression: TST001 dose dependently inhibits tumor growth, TST001 exhibits more potent antitumor activity than IMAB362-analog at the same dose (10mg/kg), and more mice reached tumor complete regression.

 TST001 monotherapy dose-escalation study has been completed in China and promising anti-tumor activities were observed in patients with advanced G/GEJC with CLDN18.2 expression who had failed multiple lines of prior therapies.

Conclusion and Future Directions for Research:

 TST001 in combination with CAPOX as the first line treatment of patients with advanced and metastatic G/GEJ cancer is well tolerated and encouraging preliminary anti-tumor activities have been observed.

 The recruitment for the current cohort is ongoing and the safety and efficacy of the combination of TST001+CAPOX as first line treatment for patients with advanced and metastatic G/GEJ cancer will be further evaluated.