A Clinical Study of Intratumoral MVR-C5252 (C5252) in Patients With Recurrent or Progressive Glioblastoma

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05095441
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ImmVira Pharma Co. Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Solid Tumor, Glioblastoma, Glioblastoma Multiforme, Glioblastoma Multiforme of Brain
Additional Details

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.

Arms & Interventions

Arms

Experimental: Part 1: Dose Escalation

C5252 single agent dose escalation in participants with glioblastoma

Experimental: Part 2: Dose Expansion

Recommended dose of C5252 as determined in Part 1 Dose Escalation in participants with glioblastoma

Interventions

Biological: - C5252

A single dose of C5252 will be administered up to 2mL as intratumoral injection on Day 1.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Site Contact

Randy Jensen, MD

clinicaltrials@immviragroup.com

781-718-5121

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