NCT02028442

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2012

Typical duration for phase_1

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2016

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

3.6 years

First QC Date

October 29, 2013

Last Update Submit

March 10, 2020

Conditions

Solid Tumours of Epithelial OriginMetastatic Colorectal CancerMetastatic Bladder Cancer

Outcome Measures

Primary Outcomes (2)

  • Phase 1 - Maximum Tolerated Dose

    \- Maximum tolerated dose (MTD) / maximum feasible dose (MFD) of enadenotucirev when administered by sub-acute fractionated IV injection (phase I Dose Escalation) and recommended dose for phase II.

    Up to Day 22

  • Phase 1b - Selection of suitable schedule for repeat cycle IV administration

    Open label assessment of 2 repeat cycle schedules, with expansion cohort at the MTD or MFD with best repeat cycle schedule in advanced/metastatic UBC patients.

    Up to Day 134

Study Arms (1)

Enadenotucirev

EXPERIMENTAL
Biological: Enadenotucirev

Interventions

EnadenotucirevBIOLOGICAL

Oncolytic virus

Enadenotucirev

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Serum bilirubin \< 1.5 mg/dL
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3x upper limit of normal (ULN)
  • Adequate bone marrow function:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • +18 more criteria

You may not qualify if:

  • 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)
  • Central nervous system (CNS) metastasis that is symptomatic and/or requires treatment
  • Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the drug
  • Known allergy to treatment medication or its excipients
  • Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
  • Progression on first line therapy
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

GZA ziekenhuizen campus Sint-Augustinus

Wilrijk, Antwerp, B-2610, Belgium

Location

Cliniques Universitaires St Luc

Brussels, B-1200, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

Institut Catala d Oncologica

Barcelona, 08970, Spain

Location

START - Hospital Universitario Madrid Sanchinarrio

Madrid, 28050, Spain

Location

Hospital Universitario Virgen del Rocio (HUVR)

Seville, 41013, Spain

Location

Related Publications (2)

  • Khalil DN, Prieto Gonzalez-Albo I, Rosen L, Lillie T, Stacey A, Parfitt L, Soff GA. A tumor-selective adenoviral vector platform induces transient antiphospholipid antibodies, without increased risk of thrombosis, in phase 1 clinical studies. Invest New Drugs. 2023 Apr;41(2):317-323. doi: 10.1007/s10637-023-01345-8. Epub 2023 Mar 10.

    PMID: 36897458DERIVED

  • Machiels JP, Salazar R, Rottey S, Duran I, Dirix L, Geboes K, Wilkinson-Blanc C, Pover G, Alvis S, Champion B, Fisher K, McElwaine-Johnn H, Beadle J, Calvo E. A phase 1 dose escalation study of the oncolytic adenovirus enadenotucirev, administered intravenously to patients with epithelial solid tumors (EVOLVE). J Immunother Cancer. 2019 Jan 28;7(1):20. doi: 10.1186/s40425-019-0510-7.

    PMID: 30691536DERIVED

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsUrinary Bladder Neoplasms

Interventions

enadenotucirev

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2013

First Posted

January 7, 2014

Study Start

September 20, 2012

Primary Completion

April 29, 2016

Study Completion

April 29, 2016

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

BE(3)ES(3)