HyPeR: Phase1 - combination of pembrolizumab with guadecitabine

• Research type

  Research Study

• Full title

  HyPeR: A Phase 1, Dose Escalation Study of Guadecitabine (SGI-110) a Second Generation Hypo-Methylating Agent in Combination with Pembrolizumab (MK3475) in Patients with Refractory Solid Tumours

• IRAS ID

  201385

• Contact name

  Johann De Bono

• Contact email

  johann.de-bono@icr.ac.uk

• Sponsor organisation

  The Institute of Cancer Research

• Eudract number

  2016-000760-41

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  The purpose of this study is to find out the side effects and safety of a combination of the hypomethylating agent, guadecitabine and the anti-PD1 antibody, pembrolizumab in patients with advanced solid tumours and to determine the most appropriate dose of this combination. During Part A, upto 6 patients will be treated with escalating doses of the combination of guadecitabine and pembrolizumab (fixed dose of 200mg). Once Part A has been completed the combination with the optimum safety and pharmacokinetic/pharmacodynamic profile will be taken forward to the Part B. Part B will evaluate the optimized dose/schedule identified in Part A of the study in patients with advanced solid tumours, enriching for patients with: (1) castration resistant prostate cancer and (2) non-small cell lung cancer (3) other patient populations if appropriate.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  16/LO/1605

• Date of REC Opinion

  19 Oct 2016

• REC opinion

  Further Information Favourable Opinion