Mechanism of Action Trial of ColoAd1

NCT ID: NCT02053220

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-04-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intra-tumoural cohort

Group Type: EXPERIMENTAL

Colo-Ad1

Intervention Type: BIOLOGICAL

Oncolytic virus

Intra-venous cohort

Group Type: EXPERIMENTAL

Colo-Ad1

Intervention Type: BIOLOGICAL

Oncolytic virus

Interventions

Colo-Ad1

Oncolytic virus

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

• 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

Exclusion Criteria

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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akamis Bio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario Madrid Sanchinarro CIOCC

Madrid, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 28923104 (View on PubMed)

Related Links

https://jitc.biomedcentral.com/articles/10.1186/s40425-017-0277-7

Journal link for MOA study publication

Other Identifiers

ColoAd1-1002

Identifier Type: -

Identifier Source: org_study_id