Mechanism of Action Trial of ColoAd1

NCT02053220 | Completed Phase 1

• 1 other identifier: ColoAd1-1002
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Resectable Colon Cancer; Resectable Non-small Cell Lung Cancer; Resectable Bladder Cancer; Resectable Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (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.

  Up to Day 25

Study Arms (2)

Intra-tumoural cohort

EXPERIMENTAL

Biological: Colo-Ad1

Intra-venous cohort

EXPERIMENTAL

Biological: Colo-Ad1

Interventions

Colo-Ad1 BIOLOGICAL

Oncolytic virus

Intra-tumoural cohort; Intra-venous cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• days of planned surgery (following IT administration or following first dose of IV administration) for cohorts A and B
• 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,

You may not qualify if:

• 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);
• 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

Sponsors & Collaborators

• Akamis Bio: lead

Study Sites (2)

Hospital Universitario Madrid Sanchinarro CIOCC

Madrid, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Related Publications (1)

• 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.

  PMID: 28923104 DERIVED

Related Links

• Journal link for MOA study publication

Study Design

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

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 3, 2014
• Study Start: June 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2016
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

ES (2)