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

NCT ID: NCT05095441

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2026-04-30

Brief 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).

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.

Conditions

Solid Tumor; Glioblastoma; Glioblastoma Multiforme; Glioblastoma Multiforme of Brain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Dose Escalation

C5252 single agent dose escalation in participants with glioblastoma

Group Type: EXPERIMENTAL

C5252

Intervention Type: BIOLOGICAL

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

Part 2: Dose Expansion

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

Group Type: EXPERIMENTAL

C5252

Intervention Type: BIOLOGICAL

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

Interventions

C5252

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmVira Pharma Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Countries

United States

Central Contacts

ImmVira Pharma Co., LTD

Role: CONTACT

clinicaltrials@immviragroup.com

781-718-5121

Facility Contacts

Randy Jensen, MD

Role: primary

clinicaltrials@immviragroup.com

Other Identifiers

MVR-C5252-001

Identifier Type: -

Identifier Source: org_study_id