Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors

Summary

This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumors (with focus on CRC, SCCHN, escalation phase), not responding to standard therapy.

Timeline

Start

2016-01-25

Primary completion

2021-10-08

Completion

2021-10-08

Publications

• Fakih M, Harb W, Mahadevan D, Babiker H, Berlin J, Lillie T, Krige D, Carter J, Cox C, Patel M, Parfitt L, Powell M, Rosen L. Safety and efficacy of the tumor-selective adenovirus enadenotucirev, in combination with nivolumab, in patients with advanced/metastatic epithelial cancer: a phase I clinical trial (SPICE). J Immunother Cancer. 2023 Apr;11(4):e006561. doi: 10.1136/jitc-2022-006561.
• Khalil DN, Prieto Gonzalez-Albo I, Rosen L, Lillie T, Stacey A, Parfitt L, Soff GA. A tumor-selective adenoviral vector platform induces transient antiphospholipid antibodies, without increased risk of thrombosis, in phase 1 clinical studies. Invest New Drugs. 2023 Apr;41(2):317-323. doi: 10.1007/s10637-023-01345-8. Epub 2023 Mar 10.

Drugs

Indications