Phase 1/1b study of Medi3726 for castration resistant prostate cancer

• Research type

  Research Study

• Full title

  A Phase 1/1b Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI3726 in Subjects with Metastatic Castration Resistant Prostate Cancer who have Received Prior Treatment with Abiraterone or Enzalutamide

• IRAS ID

  217622

• Contact name

  Johann DeBono

• Contact email

  Johann.De-Bono@icr.ac.uk

• Sponsor organisation

  MedImmune, LLC, a wholly owned subsidiary of AstraZeneca plc

• Eudract number

  2016-004391-21

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  This research study is designed to test whether the experimental drug called MEDI3726, is safe and effective in treating a specific type of prostate cancer called metastatic castration resistant prostate cancer (mCRPC), when given alone or in combination with a standard therapy called enzalutamide. This study will be conducted at 1 centre in the UK, 1 centre in Switzerland and 3 centres in the US.
  This study is divided into two parts: Part 1 (dose-escalation) and Part 2 (dose-expansion).

  In part 1 there are three different dose escalation arms A, B, C:
  In Arm A approximately up to 144 adult (at least 18 years of age) patients who have previously received standard therapy of two different kinds of treatment (one kind of treatment is called ’anti-androgen’, the other kind is a chemotherapy) will enter the study and will receive different doses of MEDI3726. In Arm B a minimum of 12 patients (at least 18 years of age) who have previously received an anti-androgen therapy but have not yet received a chemotherapy treatment will be enroled. In Arm C a minimum of 12 patients who have previously received an anti-androgen therapy called abiraterone and may or may not have received a chemotherapy treatment will be enroled.

  In Part 2 there will be 2 groups. In Group 1: Up to 28 patients who have previously received an anti-androgen therapy and chemotherapy treatment will be enrolled.
  In Group 2 up to 28 patients who have previously received an anti-androgen therapy but have not yet received a chemotherapy treatment will be enrolled.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  17/LO/0018

• Date of REC Opinion

  6 Mar 2017

• REC opinion

  Further Information Favourable Opinion