What side effects are associated with this type of intervention?

Common treatments for prostate cancer include immunotherapy, androgen deprivation therapy (ADT), chemotherapy, and radiation therapy. Immunotherapy, such as the oncolytic adenovirus ORCA-010, can cause side effects like flu-like symptoms, fatigue, and injection site reactions. ADT often leads to hot flashes, decreased libido, fatigue, and an increased risk of cardiovascular issues. Chemotherapy, particularly with taxanes like docetaxel, can result in nausea, hair loss, neuropathy, and increased susceptibility to infections. Radiation therapy may cause urinary and bowel issues, as well as fatigue and skin reactions. Each treatment has a unique side effect profile that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including immunotherapies and targeted therapies. One notable immunotherapy is sipuleucel-T, an autologous cellular immunotherapy designed to stimulate an immune response against prostate cancer. Additionally, immune checkpoint inhibitors like pembrolizumab have been approved for metastatic castration-resistant prostate cancer (CRPC) with specific genetic markers such as dMMR or high TMB. While there are no specific FDA-approved oncolytic viruses for prostate cancer similar to ORCA-010, these immunotherapies represent significant advancements in leveraging the body's immune system to combat prostate cancer.

What other types of research exist?

Promising novel alternatives to ORCA-010 for prostate cancer treatment in 2024 include CTL102, an adenovirus encoding the bacterial nitroreductase enzyme used in combination with prodrug CB1954, and Ad3-hTERT-E1A, a non-Ad5 based oncolytic adenovirus. Both therapies have shown potential in clinical trials and preclinical studies.

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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

Must not have

Prior use of chemotherapy/hormone therapy for treatment of cancer

Target tumor adherent to a major vascular structure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment where a special virus is injected directly into prostate tumors. It targets patients who have just been diagnosed and haven't had any other treatments. The virus works by infecting and killing the cancer cells, helping to reduce the size of the tumor. Early-stage trials have shown potential for this approach in treating prostate cancers that do not respond to hormone therapy.

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.

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.

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 below

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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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously used chemotherapy or hormone therapy for cancer.

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My tumor is attached to a major blood vessel.

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I have had radiation or seed implant therapy for prostate cancer.

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I have not had cancer, other than skin cancer, in the last 5 years.

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I am not taking any blood thinners except for low-dose aspirin.

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I haven't taken antiviral medication in the last 3 months.

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I do not have any serious ongoing infections.

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I do not have HIV, Hepatitis B, or Hepatitis C.

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My tumor cannot be reached for treatment by injection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~365 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety profile of ORCA-010

Secondary study objectives

Antitumor immune responses

Biological activity of ORCA-010

Shedding of ORCA-010

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments work through various mechanisms to target and destroy cancer cells. Oncolytic adenoviruses, like ORCA-010, selectively infect and lyse cancer cells, sparing normal cells and stimulating an immune response against the tumor. Androgen signaling inhibitors block the action of androgens, which fuel prostate cancer growth. Cytotoxic chemotherapy kills rapidly dividing cells, including cancer cells, by interfering with cell division. Immunotherapy, such as sipuleucel-T, enhances the body's immune system to recognize and attack cancer cells. These treatments are crucial as they offer multiple strategies to manage and potentially eradicate prostate cancer, improving patient outcomes and quality of life.

Preclinical safety assessment of Ad[I/PPT-E1A], a novel oncolytic adenovirus for prostate cancer.