A Phase I trial of ONX-0801

• Research type

  Research Study

• Full title

  A Phase I trial of ONX-0801 (a novel α-folate receptor mediated thymidylate synthase inhibitor) exploring once weekly and alternate week dosing regimens in patients with solid tumours

• IRAS ID

  125152

• Contact name

  Udai Banerji

• Contact email

  udai.banerji@icr.ac.uk

• Sponsor organisation

  The Institute of Cancer Research

• Eudract number

  2013-000569-34

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  This is an open label single centre dose escalation Phase I trial of ONX-0801. The study will evaluate 2 schedules of administration concurrently, once weekly and alternate week dosing. The study will consist of 2 parts, a dose escalation phase in which cohorts of 3-6 patients will be treated at up to 4 different dose levels to determine the recommended Phase II dose (RP2D) and schedule, and a dose expansion phase in which up to 30 patients will be treated using the RP2D and schedule. Patients in the dose expansion will be limited to those with tumours expected to express high levelsf the α-folate receptor, such as ovarian or endometrial. A minimum of 20 patients with platinum resistant/refractory ovarian cancer will be enrolled in the expansion cohort.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  13/LO/0935

• Date of REC Opinion

  19 Jul 2013

• REC opinion

  Favourable Opinion