Safety and Bioimaging Trial of DS-8895a in Patients With Advanced EphA2 Positive Cancers

Summary

This was a Phase 1, dose-escalation, non-randomized, open-label, single-center study of DS-8895a in patients with advanced or metastatic Ephrin type-A receptor 2 (EphA2)-positive cancers. The primary study objective was to determine the safety of DS-8895a, with secondary objectives of determining the biodistribution, tumor uptake (bioimaging), pharmacokinetics (PK), antitumor and pharmacodynamic response, and correlations between pharmacodynamics and clinical outcomes, as appropriate.

Timeline

Start

2014-12-09

Primary completion

2016-09-08

Completion

2016-09-08

Publications

• Gan HK, Parakh S, Lee FT, Tebbutt NC, Ameratunga M, Lee ST, O'Keefe GJ, Gong SJ, Vanrenen C, Caine J, Giovannetti M, Murone C, Scott FE, Guo N, Burvenich IJG, Paine C, Macri MJ, Kotsuma M, Senaldi G, Venhaus R, Scott AM. A phase 1 safety and bioimaging trial of antibody DS-8895a against EphA2 in patients with advanced or metastatic EphA2 positive cancers. Invest New Drugs. 2022 Aug;40(4):747-755. doi: 10.1007/s10637-022-01237-3. Epub 2022 Apr 11.

Drugs

Indications