Expanded Access Program for GBM Subjects

Expanded Access to RZ-001 in Combination with Valganciclovir in the Treatment of Subjects with Glioblastoma

This small-size patient population expanded access program is to provide access to investigational product RZ-001 for up to around 4 patients with human telomerase reverse transcriptase(hTERT)-positive Glioblastoma (GBM) who are not eligible to participate in the RZ-001-201 clinical study or in any other study involving the use of RZ-001

Study Overview

• Status: Available
• Conditions: Glioblastoma
• Intervention / Treatment: Drug: RZ-001

Detailed Description

This expanded access protocol provides expanded access to RZ-001 to patients with glioblastoma. After provision of written informed consent, subjects will be evaluated for eligibility during the Screening period, a period of 28 days prior to the RZ-001 administration on Day 1. Subjects will then undergo treatment, 8 weeks of follow-up, and bimonthly or quarterly (after 6 months from RZ-001 administration) survival follow-up.

• Study Type: Expanded Access
• Expanded Access Type: Individual Patients; Intermediate-size Population

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Available
      • Brigham & Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males and females legally considered to be adults in the country in which they are participating in the study.
2. Histologically-confirmed Grade 4 astrocytoma, GBM, per The 2021 WHO Classification of central nervous system (CNS) Tumors.
3. Recurrent GBM with radiographic evidence of the PD (progressive disease) which contains measurable disease (≥ 1 cm bidirectional diameters) by contrast-enhancement on MRI, as defined by the mRANO (modified Response Assessment in Neuro-Oncology) criteria. Only localized unifocal or multifocal recurrence is allowed, while other type of recurrences such as intraventricular, diffuse recurrence are not allowed.

Exclusion Criteria:

1. Diagnosis of other malignant tumors within 5 years prior to RZ-001 administration.
2. Have received chemotherapy within 4 weeks, and/or immunomodulatory therapy, immunotherapy, antibody therapy, gene vector therapy, vaccine therapy, and/or matrix metalloprotease inhibitor(s) within 3 months from Screening.
3. Have received radiotherapy within 12 weeks from Screening.
4. Have extracranial metastases of the tumor cells.
5. The subject is eligible for participation in any ongoing clinical study with RZ-001, or has already received RZ-001 in the past.
6. The subject is being transferred from an ongoing clinical study for which they are still eligible.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Rznomics, Inc.

Study record dates

Study Registration Dates

• First Submitted: October 27, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: RZ-001-201-EAP