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Virus Therapy
HB-302/HB-301 Therapy for Prostate Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Hookipa Biotech GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment in men with metastatic castration-resistant prostate cancer. The treatment involves receiving two different vectors (a virus that delivers therapeutic genetic material to cells), one after the other. The trial will have a dose escalation phase to determine the best dose, followed by a phase to confirm that dose and expand the study to more patients.
Who is the study for?
Men over 18 with metastatic castration-resistant prostate cancer, who've had treatment with androgen receptor inhibitors but no chemotherapy (except docetaxel in a specific setting). They must have bone metastasis, testosterone under a certain level, and an ECOG performance status of 0-1. Participants need to show disease progression after standard care.Check my eligibility
What is being tested?
The trial is testing HB-302/HB-301 alternating therapy for advanced prostate cancer. It's divided into two phases: Phase 1 to find the safest dose and Phase 2 to confirm this dose's effectiveness on more participants.See study design
What are the potential side effects?
While not specified here, potential side effects may include typical reactions to immunotherapy such as fatigue, flu-like symptoms, pain at injection site, allergic reactions or autoimmune responses where the body attacks its own cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Phase I
Phase II
Trial Design
1Treatment groups
Experimental Treatment
Group I: HB-302/HB-301 Alternating 2-Vector Therapy Intravenously (IV)Experimental Treatment1 Intervention
HB-302/HB-301 Alternating 2-Vector Therapy Intravenously (IV)
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Who is running the clinical trial?
Hookipa Biotech GmbHLead Sponsor
5 Previous Clinical Trials
398 Total Patients Enrolled
Chief Medical OfficerStudy DirectorHookipa Biotech GmbH
123 Previous Clinical Trials
21,624 Total Patients Enrolled
1 Trials studying Prostate Cancer
179 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have pain or symptoms from my illness or bone spread that aren't managed well.I am currently on medication for an infection.My cancer is resistant to hormone therapy, and my testosterone levels are low.I have been treated with a specific prostate cancer medication.I have received a transplant from another person.I am a man aged 18 or older.I haven't taken any long-term immune-weakening medication in the last 6 months.I stopped taking antiandrogen/ARSI at least 2 weeks ago, but I am still on LHRH therapy.I haven't had a live vaccine in the last 30 days or have approval if I did.I have taken medication that affects my immune system.I do not have any serious health issues that could make the study risky for me.I am fully active or can carry out light work.My cancer has spread to my brain or spinal cord.My condition worsened despite standard treatment.I have been treated for an autoimmune disease in the last 2 years.I have a history of Hepatitis B or active Hepatitis C.I have been diagnosed with HIV.My prostate cancer has spread and does not have neuroendocrine or small cell features.I finished my curative radiation therapy at least 4 weeks ago, or my palliative radiation therapy at least 2 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: HB-302/HB-301 Alternating 2-Vector Therapy Intravenously (IV)
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.
Are there opportunities for recruitment to this experiment?
"Clinicialtrials.gov reports that this trial, which was first published on December 1st 2022 and last updated on November 17th 2022 is no longer looking for new enrollees; however there are still 1258 other medical studies recruiting participants at the moment."
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