Mechanism of Action Trial of ColoAd1

Phase 1

Completed

• Conditions: Resectable Bladder Cancer; Resectable Renal Cell Carcinoma; Resectable Colon Cancer; Resectable Non-small Cell Lung Cancer
• Interventions: Biological: Colo-Ad1

• Registration Number: NCT02053220
• Lead Sponsor: Akamis Bio

Brief Summary

To assess the pattern of ColoAd1 viral delivery and viral expression within colon tumour tissue when administered by intra-tumoural injection or within colon, non-small cell lung, bladder and renal cell tumour tissues following ColoAd1 administration by intravenous infusion.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-03
• Primary Completion: 2015-04
• Study Completion: 2016-04
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intra-tumoural cohort	Colo-Ad1	-
Intra-venous cohort	Colo-Ad1	-

Primary Outcome Measures

Name	Time	Method
Composite measure of viral delivery and spread	Up to Day 25	To assess the pattern of viral delivery and viral spread of ColoAd1 within tumour tissue when administered either by intra-tumoural injection or by intravenous infusion. Viral delivery and spread will be measured by immunohistochemical staining for ColoAd1 in tumour sections taken from patients. Presence of virus will also be detected by qPCR analysis of tumour tissue.

Trial Locations

Locations (2)

Hospital Universitario Virgen del Rocío; 🇪🇸 Seville, Spain

Hospital Universitario Madrid Sanchinarro CIOCC; 🇪🇸 Madrid, Spain