A Study of APX3330 in Patients With Advanced Solid Tumors

Summary

This is a Phase 1, multi-center, open-label, dose-escalation oncology study of APX3330 in patients with advanced solid tumors.

Timeline

Start

2018-01-30

Primary completion

2018-08-18

Completion

2019-01-09

Publications

• Background Shah F, Logsdon D, Messmann RA, Fehrenbacher JC, Fishel ML, Kelley MR. Exploiting the Ref-1-APE1 node in cancer signaling and other diseases: from bench to clinic. NPJ Precis Oncol. 2017;1:19. doi: 10.1038/s41698-017-0023-0. Epub 2017 Jun 8.
• Background Jiang A, Gao H, Kelley MR, Qiao X. Inhibition of APE1/Ref-1 redox activity with APX3330 blocks retinal angiogenesis in vitro and in vivo. Vision Res. 2011 Jan;51(1):93-100. doi: 10.1016/j.visres.2010.10.008. Epub 2010 Oct 14.
• Results Safi Shahda, Nehal J. Lakhani, Bert O'Neil, Drew W. Rasco, Jun Wan, Amber L Mosley, Hao Liu, Mark R. Kelley, Richard Adam Messmann. A phase I study of the APE1 protein inhibitor APX3330 in patients with advanced solid tumors. Journal of Clinical Oncology. Volume 37: Issue 15_suppl.
• Kelley MR, Wan J, Liu S, Kpenu E, Wireman R, Mosley AL, Liu H, Lakhani NJ, Shahda S, O'Neil B, Opyrchal M, Messmann RA. A phase I study targeting the APE1/Ref-1 redox signaling protein with APX3330: first clinical agent targeting APE1/Ref-1 in cancer. Oncologist. 2026 Jan 17;31(2):oyaf423. doi: 10.1093/oncolo/oyaf423.
• Kelley MR, Wan J, Liu S, Kpenu E, Wireman R, Mosley AL, Liu H, Lakhani NJ, Shahda S, O'Neil B, Opyrchal M, Messmann RA. A Phase I study targeting the APE1/Ref-1 redox signaling protein with APX3330: First clinical agent targeting APE1/Ref-1 in Cancer. medRxiv [Preprint]. 2025 Apr 4:2025.04.03.25325173. doi: 10.1101/2025.04.03.25325173.
• Lalunio H, Stupka N, Goodman CA, Hayes A. The Potential of Targeting APE1/Ref-1 as a Therapeutic Intervention for Duchenne Muscular Dystrophy. Antioxid Redox Signal. 2025 May;42(13-15):641-654. doi: 10.1089/ars.2024.0620. Epub 2024 Dec 27.

Drugs

Indications