AzTrials
AzTrials

Resectable Colon CancerPhase 1MOANCT02053220

Mechanism of Action Trial of ColoAd1

A Phase 1 study testing Colo-Ad1 in people with Resectable Colon Cancer and Resectable Non-small Cell Lung Cancer, run by Akamis Bio at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Colo-Ad1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
2 sitesSpain
Study dates
Jun 2013to Apr 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all the following criteria to be eligible for participation:
  • Able and willing to provide written informed consent and to comply with the study protocol
  • Age ≥ 18 years
  • Patients with histologically confirmed resectable colon cancer, NSCLC (squamous and non-squamous), bladder cancer (urothelial cell carcinoma) or RCC (renal cell carcinoma), scheduled for resection of primary tumour and with planned resection of draining lymph nodes for colon cancer
  • Diagnostic colonoscopy performed at the study centre (Cohorts A and B only) or a referral centre (Cohort B only) and a report from this colonoscopy available for the study
  • Tumour size of 3 cm or more in diameter as estimated during diagnostic colonoscopy for cohorts A and B or by CT-scan for cohorts C, D and E.
Show all 28Show fewer
  • At least 2 weeks since the last dose of any intravenous systemic chemotherapy at time of first administration of ColoAd1
  • Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies.
  • Able to undergo surgery with general anaesthesia
  • Surgery planned and administration of ColoAd1 feasible within
  • 15 days of planned surgery (following IT administration or following first dose of IV administration) for cohorts A and B
  • 10 - 25 days of first ColoAd1 administration for cohorts C, D and E
  • ECOG Performance Status Score of 0 or 1
  • 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,
  • Absence of clinically significant haematuria on urinalysis: dipstick < 2+
  • Absence of clinically significant proteinuria on urinalysis: dipstick < 2+.
  • Adequate hepatic function
  • serum bilirubin <1.5 x ULN
  • AST and ALT ≤ 3 x ULN
  • Adequate bone marrow function:
  • ANC ≥ 1.5 x 109/L,
  • platelets ≥ 100 x 109/L,
  • haemoglobin ≥ 90 g/L
  • Adequate coagulation tests: INR ≤ 1.5 x ULN;
  • For females of childbearing potential (defined as <2 years after last menstruation or not surgically sterile), a negative pregnancy test must be documented prior to enrolment;
  • For women who are not postmenopausal (24 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year (e.g., hormonal implants, combined oral contraceptives, vasectomized partner), during the treatment period and for at least 3 months after the last dose of study drug;
  • For men: agreement to use a barrier method of contraception during the treatment period and for at least 6 months after the last dose of study drug

Who cannot join

  • Patients who meet any of the following criteria are not eligible for enrolment:
  • Rectal tumours; (cohorts A and B);
  • An obstructive tumour of the intestine (cohorts A and B only) or of the urinary tract (cohort D);
  • Any condition necessitating surgery in less than 8 days (cohorts A or B) or 10 days (cohorts C, D or E);
  • Pregnant or lactating (nursing) women;
  • Known and/or a history or evidence of significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids at doses higher than dexamethasone 10 mg or equivalent, or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks);
Show all 21Show fewer
  • 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, 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 PEG-IFN (within 14 days prior to day 1);
  • 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)
  • Known CNS metastasis
  • Inflammatory diseases of the bowel (cohorts A and B only) or any inflammatory disease that may require treatment with corticosteroids.
  • 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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Universitario Madrid Sanchinarro CIOCC

    Madrid

  • Hospital Universitario Virgen del Rocío

    Seville

Other trials in Spain

About this study

Official title: A Phase 1 Clinical Study of Intra-tumoural Injection or Intravenous Infusion of a Group B Oncolytic Adenovirus (ColoAd1) in Patients With Cancer Who Are Candidates for Resection of Primary Tumour

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.

Being tested
Colo-Ad1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colo-Ad1Biological

    Oncolytic virus

Study groups in NCT02053220
Study groupRoleWhat they receive
Intra-tumoural cohortExperimentalNot described
Receives: Biological: Colo-Ad1
Intra-venous cohortExperimentalNot described
Receives: Biological: Colo-Ad1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite measure of viral delivery and spread

    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.

    Measured: Up to Day 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2014 (estimated)
  2. Study startJun 2013
  3. Primary completionApr 2015
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02053220
Sponsor's protocol ID
ColoAd1-1002
Acronym
MOA
Status last verified
Mar 2020
First submitted
30 Jan 2014
Last updated
12 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • Garcia-Carbonero R, Salazar R, Duran I, Osman-Garcia I, Paz-Ares L, Bozada JM, Boni V, Blanc C, Seymour L, Beadle J, Alvis S, Champion B, Calvo E, Fisher K. Phase 1 study of intravenous administration of the chimeric adenovirus enadenotucirev in patients undergoing primary tumor resection. J Immunother Cancer. 2017 Sep 19;5(1):71. doi: 10.1186/s40425-017-0277-7.

    PubMed 28923104

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Colo-Ad1 in people with Resectable Colon Cancer and Resectable Non-small Cell Lung Cancer, run by Akamis Bio at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite measure of viral delivery and spread (time frame: Up to Day 25). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02053220, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in