Clinical Study to Evaluate OrienX010 in Combination With Toripalimab as Neoadjuvant Treatment in Advanced Melanoma

Summary

This study is an open-label, Phase Ib clinical study to evaluate recombinant human GM-CSF herpes simplex virus intratumoral injection (OrienX010) in combination with recombinant humanized anti-PD-1 monoclonal antibody infusion (Toripalimab) as neoadjuvant treatment in patients with complete resectable stage III and IV (M1a) melanoma. This study is planned to enroll approximately 30 patients with stage III and IV melanoma (M1a) who meet protocol requirements. This study is to evaluate the efficacy and safety of recombinant human GM-CSF herpes simplex virus intratumoral injection (OrienX010) in combination with recombinant humanized anti-PD-1 monoclonal antibody infusion (Toripalimab infusion) as neoadjuvant treatment in the patients with complete resectable stage III and IV (M1a) melanoma.

Timeline

Start

2019-05-27

Primary completion

2021-05-27

Completion

2025-05-27

Publications

• Zhao Q, Du Y, Li L, Mao L, Wang X, Xu Z, Liu J, Cui C, Chi Z, Gao X, Liu K, Chang S, Kong Y, Sheng X, Xia X, Guo J, Dai J, Si L. Long-term survival benefit of neoadjuvant oncolytic virus plus PD-1 blockade in acral melanoma: implications of STING in resistance and potential therapy. Exp Hematol Oncol. 2026 Jun 1. doi: 10.1186/s40164-026-00786-0. Online ahead of print.
• Liu J, Wang X, Li Z, Gao S, Mao L, Dai J, Li C, Cui C, Chi Z, Sheng X, Lai Y, Tan Z, Lian B, Tang B, Yan X, Li S, Zhou L, Wei X, Li J, Guo J, Si L. Neoadjuvant oncolytic virus orienx010 and toripalimab in resectable acral melanoma: a phase Ib trial. Signal Transduct Target Ther. 2024 Nov 22;9(1):318. doi: 10.1038/s41392-024-02029-2.

Drugs

Indications