- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05095441
A Clinical Study of Intratumoral MVR-C5252 (C5252) in Patients With Recurrent or Progressive Glioblastoma
October 9, 2022 updated by: ImmVira Pharma Co. Ltd
A Phase 1 Open-Label Study of Genetically Engineered Oncolytic HSV-1 (C5252) Expressing IL-12 and Anti-PD-1 Antibody in Patients With Recurrent or Progressive Glioblastoma
This is a Phase 1 open label, first in human study of C5252 monotherapy designed to determine the safety and tolerability of a single intratumoral (IT) injection of C5252 in patients with recurrent or progressive glioblastoma (GBM).
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
This is a Phase 1 open label, first in human study of C5252 monotherapy designed to determine the safety and tolerability of a single IT injection of C5252 in patients with recurrent or progressive GBM.
The Part 1 portion of the study is a 3+3 design to evaluate escalating doses of C5252.
Total enrollment will depend on the toxicities and/or activity observed, with approximately 36 evaluable participants enrolled.
Once the recommended dose (RD) is identified from Part 1, Part 2 Dose Expansion will enroll up to 15 additional participants to further assess the safety, tolerability, and preliminary efficacy of a single IT injection of C5252 monotherapy.
Study Type
Interventional
Enrollment (Anticipated)
51
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ImmVira Pharma Co., LTD
- Phone Number: 781-718-5121
- Email: clinicaltrials@immviragroup.com
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Contact:
- Randy Jensen, MD
- Email: clinicaltrials@immviragroup.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Signed and dated approved informed consent form (ICF) before any protocol-directed screening procedures are performed.
- Participants must have histopathologically confirmed recurrent supratentorial glioblastoma.
- Participants must have progressed after at least 1 line but no more than 2 lines of therapy.
- Evidence of progression by RANO criteria based on MRI scan.
- Residual lesion must be ≥ 1.0 cm and < 5.5 cm contrast-enhancing in diameter as determined by MRI.
- Age ≥ 18 years.
- Karnofsky Performance Score (KPS) ≥ 70.
- Life expectancy > 12 weeks.
- Participants must have normal organ and marrow function.
- Participants must commit to the use of a reliable method of birth control.
- Resolution of all AEs due to previous therapies to ≤ Grade 1 or baseline.
- Capable of understanding and complying with protocol requirements.
Key Exclusion Criteria:
- Inability to undergo MRI examination for any reason.
- A contrast-enhancing brain tumor that does not meet protocol criteria.
- Prior history of encephalitis, multiple sclerosis, or other CNS infection.
- Clinical diagnosis of Li-Fraumeni Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.
- Required steroid increase within 2 weeks prior to date of C5252 administration.
- Systemic therapy with immunosuppressive agents within 28 days prior to date of C5252 administration.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other medical condition that precludes surgery. Also, psychiatric illness/social situations that would limit compliance with study requirements.
- Bleeding diathesis, or requirement for anticoagulants, or antiplatelet agents, including NSAIDs that cannot be stopped for surgery or biopsy.
- Current diagnosis of other cancer except in situ cervical cancer, basal or squamous cell carcinoma of the skin.
- Requires continued concurrent therapy with any drug active against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir).
- Pregnant or lactating.
- Prior organ transplantation.
- Active hepatitis B virus, hepatitis C virus, or a positive serological test at Screening.
- Active oral herpes lesion at Screening.
- Congestive heart failure (> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest), or clinically significant cardiac arrhythmias.
- History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody.
- Active infection with SARS-CoV-2 virus.
- Other systemic conditions or organ abnormalities that, in the opinion of the Investigator, may interfere with the conduct and/or interpretation of the current study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: Dose Escalation
C5252 single agent dose escalation in participants with glioblastoma
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A single dose of C5252 will be administered up to 2mL as intratumoral injection on Day 1.
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Experimental: Part 2: Dose Expansion
Recommended dose of C5252 as determined in Part 1 Dose Escalation in participants with glioblastoma
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A single dose of C5252 will be administered up to 2mL as intratumoral injection on Day 1.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the safety and tolerability of C5252
Time Frame: Up to 28 days from C5252 injection
|
Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
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Up to 28 days from C5252 injection
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Characterize Dose Limiting Toxicities
Time Frame: Up to 28 days from C5252 injection
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Incidence of DLTs
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Up to 28 days from C5252 injection
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Identify the maximum tolerated dose (MTD) and/or the RD of C5252
Time Frame: Up to 28 days from C5252 injection
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Incidence of DLTs
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Up to 28 days from C5252 injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the PK of C5252
Time Frame: Up to 2 years from C5252 injection
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Measure anti-PD-1 antibody concentration in blood using Anti-PD-1 antibody ELISA test and IL-12 concentration in blood using IL-12p70 ELISA test.
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Up to 2 years from C5252 injection
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Evaluate the viral shedding of C5252
Time Frame: Up to 2 years from C5252 injection
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Measure viral shedding of C5252 after intratumoral injection in saliva, nasopharyngeal mucus, and urine using qPCR (quantitative polymerase chain reaction) test.
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Up to 2 years from C5252 injection
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Overall response rate (ORR)
Time Frame: Up to 2 years from C5252 injection
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ORR is defined as the proportion of participants who have had a partial response (PR), or complete response (CR) to intervention, based on Investigator Assessment for Neuro-oncology (RANO).
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Up to 2 years from C5252 injection
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Progression-free survival (PFS)
Time Frame: Up to 2 years from C5252 injection
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PFS is defined as the time from Day 1 to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RANO.
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Up to 2 years from C5252 injection
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Overall Survival (OS)
Time Frame: Up to 2 years from C5252 injection
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OS is defined as the time from enrollment to death from any cause.
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Up to 2 years from C5252 injection
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate blood cytokines
Time Frame: Up to 28 days from C5252 injection
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Measure blood cytokines using MSD V-Plex Electrochemiluminescence Immunoassay test.
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Up to 28 days from C5252 injection
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Evaluate lymphocyte profiling
Time Frame: Up to 28 days from C5252 injection
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Conduct lymphocyte profiling using PBMC Flow cytometry test.
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Up to 28 days from C5252 injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 15, 2023
Primary Completion (Anticipated)
April 30, 2023
Study Completion (Anticipated)
April 30, 2026
Study Registration Dates
First Submitted
September 15, 2021
First Submitted That Met QC Criteria
October 14, 2021
First Posted (Actual)
October 27, 2021
Study Record Updates
Last Update Posted (Actual)
October 12, 2022
Last Update Submitted That Met QC Criteria
October 9, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MVR-C5252-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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