A phase 1b study of Gevokizumab in patients with mCRC, mGEC and mRCC

• Research type

  Research Study

• Full title

  Phase Ib study of gevokizumab in combination with standard of care anti-cancer therapies in patients with metastatic colorectal cancer, gastroesophageal cancer and renal cell carcinoma

• IRAS ID

  259566

• Contact name

  Naureen Starling

• Contact email

  Naureen.Starling@rmh.nhs.uk

• Sponsor organisation

  Novartis Pharmaceutical UK Limited

• Eudract number

  2018-003952-19

• Clinicaltrials.gov Identifier

  NCT03798626

• Duration of Study in the UK

  4 years, 6 months, 27 days

• Research summary

  The purpose of this phase Ib study is to determine the pharmacodynamically active dose (PAD) of gevokizumab monotherapy. Also to determine tolerable dose and efficacy of gevokizumab in combination with the standard of care (SOC) anti-cancer therapies in patients with metastatic colorectal cancer (mCRC), metastatic gastroesophageal cancer (mGEC) and metastatic renal cell carcinoma (mRCC).
  The study will recruit subjects into four cohorts: A (first line mCRC), B (second line mCRC), C (second line mGEC), and D (second/third line mRCC), and will include three parts: Part 1a (dose finding, cohorts A/B), Part 1b (safety run-in, cohorts A/B/C/D) and Part 2 (expansion, cohorts A/B/C/D). Approximately 11 patients will be enrolled in UK across 4 sites.
  

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  19/EE/0113

• Date of REC Opinion

  24 Apr 2019

• REC opinion

  Further Information Favourable Opinion