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Phase I / II Study of Enadenotucirev by Sub-acute Fractionated IV Dosing in Cancer Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT02028442•Akamis Bio

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must provide written informed consent
•Age ≥ 18 years and the patient must be at least the legal age limit to be able to give consent within the jurisdiction the study is taking place.
•ECOG performance status 0 or 1
•Predicted life expectancy of 3 months or more
•Ability to comply with study procedures in the Investigator's opinion
•Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies
•Adequate renal function
•* Creatinine ≤ 1.5 mg/dL or calculated creatinine clearance using the Cockcroft-Gault formula ≥ 60 mL/min, or measured creatinine clearance ≥ 60 mL/min, Haematuria: dipstick ≤ 2+
•* Proteinuria: dipstick ≤ 2+
•Adequate hepatic function
+23 more criteria

Exclusion Criteria

•Pregnant or breast feeding females;
•Known history or evidence of significant immunodeficiency due to underlying illness (e.g. human immunodeficiency virus \[HIV\]/acquired immunodeficiency syndrome \[AIDS\]) and/or medication (e.g. systemic corticosteroids, or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks)
•Splenectomy
•Prior allogeneic or autologous bone marrow or organ transplantation
•Active infections requiring antibiotics, physician monitoring, or recurrent fevers \>38.0 degrees centigrade associated with a clinical diagnosis of active infection
•Active viral disease or known positive serology for HIV, hepatitis B or hepatitis C;
•Use of the following anti-viral agents: ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to day 1; or pegylated interferon (PEG-IFN) (within 14 days prior to first administration of ColoAd1)
•Administration of an investigational drug within 28 days prior to first dose of ColoAd1
•Major surgery within 4 weeks or radiotherapy within 3 weeks prior to first dose of ColoAd1
•Another primary malignancy within the past 3 years (except for non melanoma skin cancer or cervical cancer in situ)
+9 more criteria

Locations (6)

GZA ziekenhuizen campus Sint-Augustinus

Wilrijk, Antwerp, Belgium

Cliniques Universitaires St Luc

Brussels, Belgium

Ghent University Hospital

Ghent, Belgium

Institut Catala d Oncologica

Barcelona, Spain

START - Hospital Universitario Madrid Sanchinarrio

Madrid, Spain

Hospital Universitario Virgen del Rocio (HUVR)

Seville, Spain

Key Dates

Start Date

September 20, 2012

Primary Completion Date

April 29, 2016

Completion Date

April 29, 2016

Last Updated

March 12, 2020

Enrollment

ACTUAL participants

Conditions

Solid Tumours of Epithelial OriginMetastatic Colorectal CancerMetastatic Bladder Cancer

Interventions

Enadenotucirev

BIOLOGICAL

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

View study

RECRUITINGPHASE1/PHASE2

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

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