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Virus Therapy
ORCA-010 for Prostate Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Orca Therapeutics B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men between 18 and 75 years inclusive
ECOG status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 days
Awards & highlights
Study Summary
This trial is testing a new virus to treat prostate cancer in people who have not yet received treatment. The goal is to see if it is safe and tolerated.
Who is the study for?
Men aged 18-75 with localized prostate cancer, good physical health (ECOG status 0 or 1), and normal organ function can join. They must not have had previous cancer treatments or be part of other drug studies in the last year. Participants need to avoid sexual activity or use double contraception post-treatment.Check my eligibility
What is being tested?
The trial is testing ORCA-010, a new oncolytic adenovirus given directly into the tumor to treat prostate cancer. It's an early-phase study checking different doses for safety and how well patients tolerate it.See study design
What are the potential side effects?
As this is a first-in-man study for ORCA-010, specific side effects are being investigated; however, common reactions may include flu-like symptoms, fever, fatigue, injection site pain, and potential immune system responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged between 18 and 75.
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I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My kidney function, measured by eGFR, is 30 mL/min or higher.
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My liver, kidney, and blood tests are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 365 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety profile of ORCA-010
Secondary outcome measures
Antitumor immune responses
Biological activity of ORCA-010
Shedding of ORCA-010
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase IIa, Part B, Cohort 4Experimental Treatment1 Intervention
Two 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.
Group II: Phase I, Part A, Cohort 3Experimental Treatment1 Intervention
Single 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.
Group III: Phase I, Part A, Cohort 2Experimental Treatment1 Intervention
Single 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.
Group IV: Phase I, Part A, Cohort 1Experimental Treatment1 Intervention
Single 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.
Find a Location
Who is running the clinical trial?
CMX ResearchOTHER
10 Previous Clinical Trials
2,188 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,133 Patients Enrolled for Prostate Cancer
Orca Therapeutics B.V.Lead Sponsor
Cornelis GroenStudy DirectorOrca Therapeutics B.V.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man aged between 18 and 75.I have previously used chemotherapy or hormone therapy for cancer.I am fully active or restricted in physically strenuous activity but can do light work.My tumor is attached to a major blood vessel.My kidney function, measured by eGFR, is 30 mL/min or higher.I am not taking strong immune-suppressing drugs, except for low-dose topical or inhaled steroids.My scans show no cancer spread to lymph nodes, bones, or elsewhere.I have had radiation or seed implant therapy for prostate cancer.I have not had cancer, other than skin cancer, in the last 5 years.I am not taking any blood thinners except for low-dose aspirin.I haven't taken antiviral medication in the last 3 months.My liver, kidney, and blood tests are within normal ranges.I do not have any serious ongoing infections.I do not have HIV, Hepatitis B, or Hepatitis C.My prostate cancer is confirmed and has not spread outside the prostate in the last 2 years.My tumor cannot be reached for treatment by injection.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I, Part A, Cohort 3
- Group 2: Phase IIa, Part B, Cohort 4
- Group 3: Phase I, Part A, Cohort 1
- Group 4: Phase I, Part A, Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare facilities are conducting this experiment?
"This research trial is recruiting from a total of 5 sites, with 3 situated in the greater Toronto area and two additional locations offering participation. To lessen the burden on participants, it is recommended to select their closest site."
Answered by AI
Are there any openings for prospective participants in this research?
"Affirmative. According to clinicaltrials.gov, this trial is actively recruiting participants since it was first published on November 12th 2019 and most recently updated on November 16th 2022. 24 patients are needed at 5 medical facilities."
Answered by AI
Could I partake in this investigation?
"This research study is open to 24 adult males with prostate cancer between the ages of 18 and 75. Additionally, participants must meet the following prerequisites: a masculine gender identity, aged eighteen through seventy-five inclusive, and an ECOG status 0 or 1."
Answered by AI
Is it permissible for participants aged 20 or older to partake in this investigation?
"As indicated by the study's eligibility requirements, only individuals between 18 to 75 years old can participate. There are 73 studies available for those younger than 18 and 1,253 trials open to seniors over 65."
Answered by AI
What is the current threshold for participants in this experiment?
"Affirmative, according to clinicaltrials.gov this medical study is currently enrolling patients. This investigation became visible on November 12th 2019 and was most recently refreshed on November 16th 2022. It requires 24 participants from 5 distinct sites for completion."
Answered by AI
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