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

NCT05095441 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: MVR-C5252-001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 28 days from C5252 injection

• Characterize Dose Limiting Toxicities

  Incidence of DLTs

  Up to 28 days from C5252 injection

• Identify the maximum tolerated dose (MTD) and/or the RD of C5252

  Incidence of DLTs

  Up to 28 days from C5252 injection

Secondary Outcomes (5)

• Evaluate the PK of C5252

  Up to 2 years from C5252 injection

• Evaluate the viral shedding of C5252

  Up to 2 years from C5252 injection

• Overall response rate (ORR)

  Up to 2 years from C5252 injection

• Progression-free survival (PFS)

  Up to 2 years from C5252 injection

• Overall Survival (OS)

  Up to 2 years from C5252 injection

Other Outcomes (2)

• Evaluate blood cytokines

  Up to 28 days from C5252 injection

• Evaluate lymphocyte profiling

  Up to 28 days from C5252 injection

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

C5252 single agent dose escalation in participants with glioblastoma

Biological: C5252

Part 2: Dose Expansion

EXPERIMENTAL

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

Biological: C5252

Interventions

C5252 BIOLOGICAL

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

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmVira Pharma Co. Ltd: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

ImmVira Pharma Co., LTD

CONTACT

781-718-5121; clinicaltrials@immviragroup.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 27, 2021
• Study Start: March 15, 2023
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2026
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)