Status:
UNKNOWN
First in Man Clinical Study to Evaluate Safety and Tolerability of an Oncolytic Adenovirus in Prostate Cancer Patients.
Lead Sponsor:
Orca Therapeutics B.V.
Collaborating Sponsors:
CMX Research
Conditions:
Adenocarcinoma of the Prostate
Eligibility:
MALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This open label, dose escalating study is a phase I/IIa first in man study designed to evaluate the safety and tolerability of intratumoral administration of a novel oncolytic adenovirus (ORCA-010) in...
Detailed Description
The study is divided into two parts. In Part A of the study, cohorts of subjects will be administered escalating doses of ORCA-010, using the 3+3 design. When the Maximum Tolerated Dose has been deter...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate, which is localized to the prostate ( within 24 months of screening)
- Absence of lymph node, bone or other metastases as determined by MRI and CT scan, Bone Scan or nano-MRI (≤3 months prior to first administration)
- Men between 18 and 75 years inclusive
- ECOG status 0 or 1
- Ability to understand and willingness to sign informed consent
- Adequate liver, renal and bone marrow function: AST \& ALT \< 2.5 x ULN, total bilirubin \< 1.5 x ULN, Alkaline phosphatase \< 3 x ULN, Serum creatinine \< 1.5 x ULN, Haemoglobin \> 9.0 g/dL (5.59 mmol/L), Platelet count \> 100x10\*9/L, Neutrophils \> 1.5x10\*9/L, INR \< 1.5xULN
- eGFR ≥ 30 mL/min, using the Cockcroft - Gault Equation: Creatinine Clearance = \[{(140 - age in years) x (weight in kg)} x 1.23\] /serum Creatinine in Mmol/L
Exclusion
- Tumor not accessible for injection
- Prior treatment of prostate cancer with radiation therapy or brachytherapy
- Prior use of chemotherapy/hormone therapy for treatment of cancer
- Target tumor adherent to a major vascular structure
- Participation in any investigational drug study within the last 12 months prior to first administration of ORCA-010
- Clinically significant active infection (viral or bacterial)
- Known immunosuppressive diseases (e.g. HIV, Hepatitis B and C)
- History of any other oncological malignancy, excluding basal cell carcinoma of the skin, in the past 5 years
- Not willing to refrain from sexual activities or use a double barrier contraceptive device (condom with foam or vaginal suppository, diaphragm with spermicide) after administration of ORCA-010 and until 42 days after the last ORCA-010 administration
- Severe obesity defined as Body Mass Index (BMI) \> 30 kg/m2
- Positive for adenovirus in throat swap or serum as determined by PCR at screening
- Recent (within 3 months prior to enrolment in the study) history of alcohol abuse or other substances such as barbiturates, cannabinoids and amphetamines or a positive urine screen for drugs of abuse
- Use of medication known to have immunosuppressive effects, except topical/inhaled steroids under 10 mg/day prednisolone equivalent (See Appendix 7)
- Use of systemic antiviral medication within 3 months prior to enrolment in the study
- Use of any anti-coagulants/blood thinner except for ASA 81mg
- Any condition that in the opinion of the Investigator could interfere with the conduct of the study
- For Part B only: Subjects enrolled in Part A of the study
Key Trial Info
Start Date :
November 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04097002
Start Date
November 12 2019
End Date
December 1 2024
Last Update
October 31 2023
Active Locations (5)
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1
Jonathan Giddens Medicine Professional Corporation
Brampton, Ontario, Canada, L6T 4S5
2
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada, L7N 3V2
3
Research St. Joseph's - Hamilton
Hamilton, Ontario, Canada, L8N 4A6
4
The Fe/Male Health Centres Recruiting
Oakville, Ontario, Canada, L6H 3 P1