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Cancer Vaccine
hP1A8 Immunotherapy for Glioblastoma
Phase 1
Waitlist Available
Research Sponsored by OX2 Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of GBM.
Aged 18 years and older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment for brain tumors.
Who is the study for?
Adults diagnosed with recurrent glioblastoma (GBM) who have seen their disease progress or return after standard treatments like radiation and chemotherapy. They must not have used certain drugs like Bevacizumab recently, nor have immune disorders, intolerance to previous chemoradiotherapy, history of specific implanted agents, or be using tumor treatment field devices.Check my eligibility
What is being tested?
The trial is testing hP1A8 combined with imiquimod and the GBM6-AD vaccine as a new treatment for GBM. It's an early-phase study to find the right dose range and it's open-label, meaning everyone knows what treatment they're getting.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions to immunotherapy such as flu-like symptoms, injection site reactions, fatigue, fever, chills and possible autoimmune responses due to CD200AR-L activation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with glioblastoma (GBM).
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I am 18 years old or older.
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My cancer has worsened or returned after standard treatment.
Select...
I have been diagnosed with glioblastoma multiforme (GBM).
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My cancer has worsened or returned after standard treatment.
Select...
I can have surgery to reduce my tumor size or a biopsy before joining the trial, if needed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD
Secondary outcome measures
Incidence of serious adverse events (SAEs)
Overall survival (OS)
Progression free survival (PFS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: hP1A8Experimental Treatment1 Intervention
Up to 3 dose levels of hP1A8 will be tested with a Dose Level -1 in the event of toxicity. The MTD will be identified using the standard 3+3 design. Upon determination of the MTD, additional patients will be enrolled as part of an expansion cohort.
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Who is running the clinical trial?
OX2 TherapeuticsLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with glioblastoma (GBM).I have not taken Bevacizumab or targeted therapy in the last 45 days.I have a condition affecting my immune system, like HIV or an autoimmune disease.I am 18 years old or older.My cancer has worsened or returned after standard treatment.I couldn't finish my initial cancer treatment because it was too harsh or my cancer got worse.I am 18 years old or older.I have been diagnosed with glioblastoma multiforme (GBM).I can have surgery to reduce my tumor size or get a biopsy before joining the trial.My cancer has worsened or returned after standard treatment.I can have surgery to reduce my tumor size or a biopsy before joining the trial, if needed.
Research Study Groups:
This trial has the following groups:- Group 1: hP1A8
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.
What safety assessments have been conducted in regards to hP1A8 treatments?
"Our Power team gave Treatment with hP1A8 a score of 1, as this is an early-stage trial. There has only been limited research on its safety and efficacy thus far."
Answered by AI
Are there any active recruitment efforts for this clinical trial?
"Clinicaltrials.gov reports that this trial, which was initially posted on December 1st 2020, is not presently looking for participants. Nevertheless, there are still 442 other medical studies with open recruitment at the current moment in time."
Answered by AI
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