AzTrials
AzTrials

Adenocarcinoma of the ProstatePhase 1/2NCT04097002

First in Man Clinical Study to Evaluate Safety and Tolerability of an Oncolytic Adenovirus in Prostate Cancer Patients.

A Phase 1/2 study testing ORCA-010 in people with Adenocarcinoma of the Prostate, run by Orca Therapeutics B.V. at 5 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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 treating diagnosed treatment naïve Patients with localized prostate cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Adenocarcinoma of the Prostate
What is being tested?
ORCA-010
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
5 sitesCanada
Study dates
12 Nov 2019to Dec 2024
Phase
Phase 1/2
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 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Jonathan Giddens Medicine Professional Corporation

    Brampton, Ontario, L6T 4S5

  • G. Kenneth Jansz Medicine Professional Corporation

    Burlington, Ontario, L7N 3V2

  • Research St. Joseph's - Hamilton

    Hamilton, Ontario, L8N 4A6

  • The Fe/Male Health Centres Recruiting

    Oakville, Ontario, L6H 3 P1

  • Urology and Male Infertility Clinic

    Scarborough Village, Ontario, M1S 4V5

Other trials in Canada

About this study

Official title: A Phase I/IIa Study Evaluating the Safety and Tolerability of Intratumoral Administration of ORCA-010 in Treatment-Naïve Patients With Localized Prostate Cancer.

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 treating diagnosed treatment naïve Patients with localized prostate cancer.

Read the 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 determined in Part A, a group of 12 new subjects will be treated in Part B of the study at this dose, with two administrations separated by a 2-week interval.

Being tested
ORCA-010
Keywords
Prostate cancer, Intratumoral, ORCA, Adenovirus, Localized Prostate cancer, Intraprostatic
Medical subject headings
Prostatic Neoplasms, Adenoviridae Infections

What participants receive

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

  • ORCA-010Biological

    The investigational new drug ORCA-010 is a novel and improved oncolytic adenovirus based on the adenovirus serotype 5 (Ad5) genome. ORCA-010 replicates specifically in cancer cells and not in normal tissue cells. Its replication has been shown in a wide variety of cancer cell types, and it is not limited to prostate cancer.

Study groups in NCT04097002
Study groupRoleWhat they receive
Phase I, Part A, Cohort 1ExperimentalSingle dose-escalation of ORCA-010, Dose Cohort 1: 1x10*11 viral particles. Single dose of ORCA-010 will be administered for the first subject only and all relevant safety data for this subject will be reviewed by the DSMB prior to enrolling additional subjects. After the DSMB review, subjects will be enrolled in groups of three (including the first subject) and assessed for safety and Dose-Limiting Toxicity (DLT) after a single dose of ORCA-010. Group of 3 subjects. Dose will be escalated to the next cohort based on safety and toxicity results from the 3 treated subjects to determine the Maximum Tolerated Dose, if not determined by this cohort.
Receives: Biological: ORCA-010
Phase I, Part A, Cohort 2ExperimentalSingle dose-escalation of ORCA-010, Dose Cohort 2: 5x10*11 viral particles. Group of 3 subjects. Dose will be escalated to the next cohort based on safety and toxicity results from the 3 treated subjects to determine the Maximum Tolerated Dose, if not determined by this cohort.
Receives: Biological: ORCA-010
Phase I, Part A, Cohort 3ExperimentalSingle dose-escalation of ORCA-010, Dose Cohort 3: 1.5x10*12 viral particles. Group of 3 subjects. Dose will be considered as the Maximum Tolerated Dose based on safety and toxicity results from the 3 treated subjects.
Receives: Biological: ORCA-010
Phase IIa, Part B, Cohort 4ExperimentalTwo dose administration of ORCA-010 seperated by 2 weeks, Dose Cohort 4: The Maximum Tolerated Dose depending on Phase I/ Part A results. Group of 12 subjects.
Receives: Biological: ORCA-010

What is being measured

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

  1. Safety profile of ORCA-010

    To evaluate safety and tolerability of intratumoral administration of ORCA-010 according to CTCAE V5.0. The primary endpoint of this study is to assess Dose Limiting Toxicities (DLTs) and the Maximum Tolerated Dose (MTD) for ORCA-010 to determine the final safety dose of administration for Phase IIa/Part B.

    Measured: 365 days

Secondary outcomes (3)

  1. Biological activity of ORCA-010

    To explore the biological activity of intratumoral administration of ORCA-010. Biological activity of ORCA-010 will be measured by assessing viral replication by measuring ORCA-010 virus DNA in blood. In addition, virus replication and spread will be assessed by staining prostate cancer tissue obtained through prostate biopsies with adenovirus specific antibodies. Subject's serum will be assayed for antibody responses against ORCA-010.

    Measured: 365 days

  2. Antitumor immune responses

    To evaluate potential antitumor immune responses following ORCA-010 administration. Subject's serum will be analyzed for antibody responses against tumor-associated antigens (e.g. PSA, PSMA, PCA3, and Prostein). Subject's Peripheral Blood Mononuclear Cells (PBMCs) will also be analyzed for cellular immune responses against tumor-associated antigens.

    Prostate biopsies will be taken to detect local antitumor immunological reactions (eg. infiltration and activation of T cells).

    Measured: 365 days

  3. Shedding of ORCA-010

    Shedding of ORCA-010 will be assessed by detection of vector DNA in blood and urine using quantitative-PCR (Q-PCR).

    Measured: 365 days

Timeline

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

  1. First posted20 Sep 2019
  2. Study start12 Nov 2019
  3. Primary completionOct 2024 (estimated)
  4. Study completionDec 2024 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Phase I and Phase IIa. Phase I/ Part A is a Single-escalated dose of ORCA-010 (3 dose cohorts) to determine the Maximum Tolerated Dose. Phase IIa/ Part B is a two administration dose cohort at Maximum Tolerated Dose.
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04097002
Sponsor's protocol ID
CP-ORCA-010-02-CA
Other IDs
2017-002737-39, HC6-024-C227843, 2017
Status last verified
Oct 2023
First submitted
2 Aug 2019
Last updated
31 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not yet determined.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ORCA-010 in people with Adenocarcinoma of the Prostate, run by Orca Therapeutics B.V. at 5 sites in Canada.

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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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?

Safety profile of ORCA-010 (time frame: 365 days). 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 NCT04097002.

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 31 Oct 2023.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in