Solid TumorPhase 1NCT05095441
A Clinical Study of Intratumoral MVR-C5252 (C5252) in Patients With Recurrent or Progressive Glioblastoma
A Phase 1 study testing C5252 in people with Solid Tumor and Glioblastoma, run by ImmVira Pharma Co. Ltd at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Glioblastoma, Glioblastoma Multiforme
- What is being tested?
- C5252
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 30 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Randy Jensen, MD, clinicaltrials@immviragroup.com
About this study
Official title: 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).
Read the 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.
- Being tested
- C5252
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C5252Biological
A single dose of C5252 will be administered up to 2mL as intratumoral injection on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | C5252 single agent dose escalation in participants with glioblastoma Receives: Biological: C5252 |
| Part 2: Dose Expansion | Experimental | Recommended dose of C5252 as determined in Part 1 Dose Escalation in participants with glioblastoma Receives: Biological: C5252 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of C5252
Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Measured: Up to 28 days from C5252 injection
Characterize Dose Limiting Toxicities
Incidence of DLTs
Measured: Up to 28 days from C5252 injection
Identify the maximum tolerated dose (MTD) and/or the RD of C5252
Incidence of DLTs
Measured: Up to 28 days from C5252 injection
Secondary outcomes (5)
Evaluate the PK of C5252
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.
Measured: Up to 2 years from C5252 injection
Evaluate the viral shedding of C5252
Measure viral shedding of C5252 after intratumoral injection in saliva, nasopharyngeal mucus, and urine using qPCR (quantitative polymerase chain reaction) test.
Measured: Up to 2 years from C5252 injection
Overall response rate (ORR)
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).
Measured: Up to 2 years from C5252 injection
Progression-free survival (PFS)
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.
Measured: Up to 2 years from C5252 injection
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Measured: Up to 2 years from C5252 injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start15 Mar 2023 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmVira Pharma Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095441
- Sponsor's protocol ID
- MVR-C5252-001
- Status last verified
- Oct 2022
- First submitted
- 15 Sep 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05095441
- Acronym / sponsor ID
- MVR-C5252-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- ImmVira Pharma Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Biological: C5252C5252 single agent dose escalation in participants with glioblastoma |
| Part 2: Dose Expansion | Experimental | Biological: C5252Recommended dose of C5252 as determined in Part 1 Dose Escalation in participants with glioblastoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C5252A single dose of C5252 will be administered up to 2mL as intratumoral injection on Day 1. | Biological | Part 1: Dose Escalation, Part 2: Dose Expansion |
Primary outcome
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.
Characterize Dose Limiting Toxicities
Time frame: Up to 28 days from C5252 injection
Incidence of DLTs
Identify the maximum tolerated dose (MTD) and/or the RD of C5252
Time frame: Up to 28 days from C5252 injection
Incidence of DLTs
5 secondary outcomes
Evaluate the PK of C5252
Time frame: Up to 2 years from C5252 injection
Evaluate the viral shedding of C5252
Time frame: Up to 2 years from C5252 injection
Overall response rate (ORR)
Time frame: Up to 2 years from C5252 injection
Progression-free survival (PFS)
Time frame: Up to 2 years from C5252 injection
Overall Survival (OS)
Time frame: Up to 2 years from C5252 injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C5252 in people with Solid Tumor and Glioblastoma, run by ImmVira Pharma Co. Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ImmVira Pharma Co., LTD (781-718-5121, clinicaltrials@immviragroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of C5252 (time frame: Up to 28 days from C5252 injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.