GC33 in Patients with Unresectable Advanced or Metastatic HCC

• Research type

  Research Study

• Full title

  A Randomized, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients with Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)

• IRAS ID

  90922

• Contact name

  Phillip Harrison

• Sponsor organisation

  F. Hoffmann-La Roche Ltd.

• Eudract number

  2011-003574-84

• Research summary

  GC33 is a monoclonal antibody which means it is a naturally produced protein that has been designed by scientists to target a particular type of cells (in this case liver tumour cells) that carry on their surface the protein recognised by GC33, called Glypican-3 (GPC-3). In animal models, GC33 has been shown to limit tumour growth (cancer) by binding to GPC-3 on liver tumour cells and induce tumour cell destruction; this suggests that GC33 may be useful for liver cancer treatment in humans. The purpose of this randomised, placebo-controlled, double-blind, study is to find out if the study drug GC33 can help stop the growth and spread of cancer cells in patients with unresectable advanced or metastatic hepatocellular carcinoma (HCC) whose disease has progressed after previous treatment(s) or who have been intolerant to previous treatment(s), and to see if the drug may cause any side effects. This study sponsored by Roche is looking for approximately 156 people worldwide with unresectable advanced or metastatic hepatocellular carcinoma. Approximately 10 participants will be recruited in the UK. The overall duration of this study will be approximately 32 months.If the participants GPC-3 level is considered high or moderate, they will be randomly assigned to receive either GC33 or placebo. These participants will have two chances out of three to receive GC33. If their GPC-3 level is low/negative, they will not be randomised and may automatically receive GC33. This study involves procedures including: Medical History, Tumour tissue to assess level of GPC-3, pregnancy test, physical exam, vital signs, height, weight, electrocardiogram, blood tests, Urine tests, CT or MRI scan of the chest, abdomen and pelvis, study drug administration, follow-up. Participants will also have the option to donate their samples to be stored in the Roche Clinical Repository.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  11/LO/1983

• Date of REC Opinion

  21 Dec 2011

• REC opinion

  Favourable Opinion