Recombinant Human Anti-PD-1 Monoclonal Antibody HX008 Injection for the Treatment of Advanced Solid Tumors

Summary

In this study, patients of advanced gastric adenocarcinoma with failed first-line chemotherapy-line or advanced mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) advanced solid carcinoma will be treated with HX008 combined with irinotecan and HX008 monotherapy There will be two cohorts in this study: Cohort 1 and Cohort 2. For Cohort 1, advanced gastric adenocarcinoma with failed first-line chemotherapy-line cancer participants, who had failed or were unable to tolerate first line chemotherapy with platinum-based or fluorouracil regimens. For Cohort 2, advanced solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.

Timeline

Start

2018-09-30

Primary completion

2019-12-30

Completion

2021-03-30

Publications

• Zhang B, Song Y, Luo S, Yin X, Li E, Wang H, He Y, Liu Z, Fan Q, Liang X, Shu Y, Liu Y, Xu N, Zhang S, Zhuang Z, Zhang J, Kou X, Wang F, Zhu X, Zeng S, Wang K, Zhong H, Li S, Bai Y, Yu J, Dou Y, Ma T, Liu Q, Huang J. Pucotenlimab in patients with advanced mismatch repair-deficient or microsatellite instability-high solid tumors: A multicenter phase 2 study. Cell Rep Med. 2023 Dec 19;4(12):101301. doi: 10.1016/j.xcrm.2023.101301. Epub 2023 Nov 27.
• Song Y, Li N, Li Q, Liang X, Zhang S, Fan Q, Yin X, Zhuang Z, Liu Y, Zhang J, Kou X, Zhong H, Wang X, Dou Y, Huang J. HX008, an anti-PD1 antibody, plus irinotecan as second-line treatment for advanced gastric or gastroesophageal junction cancer: a multicenter, single-arm phase II trial. J Immunother Cancer. 2020 Oct;8(2):e001279. doi: 10.1136/jitc-2020-001279.

Drugs

Indications