Phase I Trial of ONX-0801 Once Weekly or Alternate Weekly

Summary

This is an open label, single-centre dose escalation phase 1 clinical trial of ONX-0801. The study will evaluate two schedules of ONX-0801 concurrently: once weekly and alternate week dosing, of repeated 28-day treatment cycles. The study will consist of two stages: the dose escalation phase, in which the recommended phase II dose will be determined; and the expansion phase, in which up to 30 patients will be treated at the recommended phase II dose and schedule to further support the design of subsequent trials of ONX-0801.

Timeline

Start

2013-09

Primary completion

2020-01

Completion

2021-03

Publications

• Results Banerjee S, Michalarea V, Ang JE, Ingles Garces A, Biondo A, Funingana IG, Little M, Ruddle R, Raynaud F, Riisnaes R, Gurel B, Chua S, Tunariu N, Porter JC, Prout T, Parmar M, Zachariou A, Turner A, Jenkins B, McIntosh S, Ainscow E, Minchom A, Lopez J, de Bono J, Jones R, Hall E, Cook N, Basu B, Banerji U. A Phase I Trial of CT900, a Novel alpha-Folate Receptor-Mediated Thymidylate Synthase Inhibitor, in Patients with Solid Tumors with Expansion Cohorts in Patients with High-Grade Serous Ovarian Cancer. Clin Cancer Res. 2022 Nov 1;28(21):4634-4641. doi: 10.1158/1078-0432.CCR-22-1268.

Drugs

Indications