Phase I / II Study of ColoAd1 by sub-acute fractionated IV dosing

• Research type

  Research Study

• Full title

  A Clinical Study Of ColoAd1 Administered by Sub-Acute Fractionated Intravenous Injection: Dose Escalation in Metastatic Epithelial Solid Tumours and Randomised Controlled Trial in Metastatic Colorectal Cancer.

• IRAS ID

  108482

• Contact name

  Rebecca Kristeleit

• Sponsor organisation

  Psioxus Therapeutics Ltd

• Eudract number

  2012-001067-79

• ISRCTN Number

  n/a

• Research summary

  This study is looking at an experimental drug called ColoAd1 for treating cancer . The drug is a virus which should only grow in, and kill, cancer cells and not healthy cells. This is the first time this experimental drug has been used in humans and it is being offered to patients whose cancer is either not responding to treatment or for which there is no treatment currently available. There are four stages to this study Phase I Dose Escalation Stage This stage will look at the safety profile of the drug. Participants will be enrolled into test groups to test four potential doses. The different test groups will take increasingly larger doses of ColoAd1 until we find an appropriate safe dose to recommend for subsequent use. Phase I Dose Expansion Stage Once a safe dose is found in the dose escalation stage, this stage will recruit further patients with colorectal cancer at that dose level to evaluate the effectiveness at that dose and further study the safety profile of the drug. This stage will also enable a review of any immune response that the patient may have to the drug. Phase II Dose Feasibility Stage This stage has been developed to test how safe and well tolerated ColoAd1 is when followed by further chemotherapy and to find out more about the side-effects of ColoAd1 in patients with colorectal cancer. This stage will attempt to answer the following questions; ?½ What are the side effects of ColoAd1followed by chemotherapy? ?½ Does ColoAd1 help to make chemotherapy more effective? ?½ Does ColoAd1 help to improve the length of time that the tumour responds to chemotherapy? Phase II Randomised Stage This stage will estimate the effectiveness of ColoAd1 followed by further chemotherapy when compared to continued chemotherapy alone in colorectal cancer patients.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  12/LO/1115

• Date of REC Opinion

  4 Sep 2012

• REC opinion

  Further Information Favourable Opinion