NCT02028442

Phase I / II Study of Enadenotucirev by Sub-acute Fractionated IV Dosing in Cancer Patients

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Akamis Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, open-label, Phase I/II study of enadenotucirev in patients with either solid tumour of epithelial origin not responding to standard therapy or for whom no standard treatment exists (Phase I dose escalation stage Single cycle), mCRC not responding to standard therapy (Phase I dose escalation Repeat cycle cohort expansion stage ), mCRC not responding to standard therapy or advanced or metastatic bladder cancer not candidate for chemotherapy (Phase Ib) or mCRC in stable disease or partial response after 3-4 months of first line standard of care chemotherapy (Phase II).

Conditions

• Solid Tumours of Epithelial Origin
• Metastatic Colorectal Cancer
• Metastatic Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Enadenotucirev	Oncolytic virus

Timeline

• Start date: 2012-09-20
• Primary completion: 2016-04-29
• Completion: 2016-04-29
• First posted: 2014-01-07
• Last updated: 2020-03-12

Locations

6 sites across 2 countries: Belgium, Spain