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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. Signed and dated approved informed consent form (ICF) before any protocol-directed screening procedures are performed.
  2. Participants must have histopathologically confirmed recurrent supratentorial glioblastoma.
  3. Participants must have progressed after at least 1 line but no more than 2 lines of therapy.
  4. Evidence of progression by RANO criteria based on MRI scan.
  5. Residual lesion must be ≥ 1.0 cm and < 5.5 cm contrast-enhancing in diameter as determined by MRI.
  6. Age ≥ 18 years.
  7. Karnofsky Performance Score (KPS) ≥ 70.
  8. Life expectancy > 12 weeks.
  9. Participants must have normal organ and marrow function.
  10. Participants must commit to the use of a reliable method of birth control.
  11. Resolution of all AEs due to previous therapies to ≤ Grade 1 or baseline.
  12. Capable of understanding and complying with protocol requirements.

Key Exclusion Criteria:

  1. Inability to undergo MRI examination for any reason.
  2. A contrast-enhancing brain tumor that does not meet protocol criteria.
  3. Prior history of encephalitis, multiple sclerosis, or other CNS infection.
  4. Clinical diagnosis of Li-Fraumeni Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.
  5. Required steroid increase within 2 weeks prior to date of C5252 administration.
  6. Systemic therapy with immunosuppressive agents within 28 days prior to date of C5252 administration.
  7. 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.
  8. Bleeding diathesis, or requirement for anticoagulants, or antiplatelet agents, including NSAIDs that cannot be stopped for surgery or biopsy.
  9. Current diagnosis of other cancer except in situ cervical cancer, basal or squamous cell carcinoma of the skin.
  10. Requires continued concurrent therapy with any drug active against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir).
  11. Pregnant or lactating.
  12. Prior organ transplantation.
  13. Active hepatitis B virus, hepatitis C virus, or a positive serological test at Screening.
  14. Active oral herpes lesion at Screening.
  15. 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.
  16. History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody.
  17. Active infection with SARS-CoV-2 virus.
  18. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Dose Escalation
C5252 single agent dose escalation in participants with glioblastoma
Biological: C5252
A single dose of C5252 will be administered up to 2mL as intratumoral injection on Day 1.
Experimental: Part 2: Dose Expansion
Recommended dose of C5252 as determined in Part 1 Dose Escalation in participants with glioblastoma
Biological: C5252
A single dose of C5252 will be administered up to 2mL as intratumoral injection on Day 1.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Up to 28 days from C5252 injection
Characterize Dose Limiting Toxicities
Time Frame: Up to 28 days from C5252 injection
Incidence of DLTs
Up to 28 days from C5252 injection
Identify the maximum tolerated dose (MTD) and/or the RD of C5252
Time Frame: Up to 28 days from C5252 injection
Incidence of DLTs
Up to 28 days from C5252 injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate the PK of C5252
Time Frame: Up to 2 years from C5252 injection
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.
Up to 2 years from C5252 injection
Evaluate the viral shedding of C5252
Time Frame: Up to 2 years from C5252 injection
Measure viral shedding of C5252 after intratumoral injection in saliva, nasopharyngeal mucus, and urine using qPCR (quantitative polymerase chain reaction) test.
Up to 2 years from C5252 injection
Overall response rate (ORR)
Time Frame: Up to 2 years from C5252 injection
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).
Up to 2 years from C5252 injection
Progression-free survival (PFS)
Time Frame: Up to 2 years from C5252 injection
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.
Up to 2 years from C5252 injection
Overall Survival (OS)
Time Frame: Up to 2 years from C5252 injection
OS is defined as the time from enrollment to death from any cause.
Up to 2 years from C5252 injection

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate blood cytokines
Time Frame: Up to 28 days from C5252 injection
Measure blood cytokines using MSD V-Plex Electrochemiluminescence Immunoassay test.
Up to 28 days from C5252 injection
Evaluate lymphocyte profiling
Time Frame: Up to 28 days from C5252 injection
Conduct lymphocyte profiling using PBMC Flow cytometry test.
Up to 28 days from C5252 injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ImmVira Pharma Co. Ltd

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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