A Clinical Trial of AdNRGM Plus CB1954 in Prostate Cancer

Summary

This is an open label, non-randomised, phase I, sequential group trial which will explore the safety and tolerability of ascending doses of AdNRGM, in combination with CB1954. Five groups of 3 patients each will be treated with escalating doses of AdNRGM (10\^10, 3x10\^10, 10\^11, 3x10\^11, 10\^12 vp) followed 2 days later by intravenous CB1954 at a fixed dose (24mg/m\^2). To ensure the coverage of the whole prostate the vector will be delivered by multiple, template-guided trans-perineal injections using an adaptation of standard prostate brachytherapy technique. Dose escalation will be dependent on safety and tolerability; at each dose-level, if dose-limiting toxicity (DLT) is seen in one patient, the cohort will be expanded to a maximum of 6 patients. If DLT is then observed in a second patient at that dose, no further patients will be recruited and the previous (lower) dose-level will be defined as the maximum tolerated dose (MTD). If DLT is seen in 0/3 or just 1/6 patients, dose escalation may continue.

Timeline

Start

2013-03-19

Primary completion

2021-08

Completion

2021-08

Publications

• Background Patel P, Young JG, Mautner V, Ashdown D, Bonney S, Pineda RG, Collins SI, Searle PF, Hull D, Peers E, Chester J, Wallace DM, Doherty A, Leung H, Young LS, James ND. A phase I/II clinical trial in localized prostate cancer of an adenovirus expressing nitroreductase with CB1954 [correction of CB1984]. Mol Ther. 2009 Jul;17(7):1292-9. doi: 10.1038/mt.2009.80. Epub 2009 Apr 14.

Drugs

Indications