Expanded Access Program for Patients with Glioblastoma (GBM)

Sponsor: Rznomics, Inc.

Expanded Access
Sponsor score: 60

ClinicalTrials ID:NCT06676891

Provider View

This program provides access to an investigational treatment, RZ-001, for up to 4 patients with a specific type of brain cancer called hTERT-positive Glioblastoma (GBM) who cannot join other clinical trials for this treatment.

Patient Parameters

Program Overview

This program allows patients with Glioblastoma (GBM) to access an investigational treatment called RZ-001. After signing a consent form, patients will be checked for eligibility over a 28-day period before starting the treatment. Following treatment, there will be an 8-week follow-up and regular check-ins every two to three months to monitor survival.

Description

The expanded access program is designed to provide the investigational drug RZ-001 to patients with Glioblastoma (GBM) who are not eligible for other clinical trials involving this drug. Once patients agree to participate and provide written consent, they will undergo a screening process lasting up to 28 days to determine if they qualify for the program. If eligible, patients will receive the treatment and be monitored for 8 weeks. After this period, follow-up visits will occur every two to three months to track their health and response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults legally recognized in their country.
  • Diagnosed with Grade 4 astrocytoma, also known as Glioblastoma (GBM), according to the 2021 WHO Classification.
  • Have recurrent GBM with measurable disease visible on an MRI scan, showing tumor growth.
  • Only localized or multifocal tumor recurrence is allowed, not widespread or intraventricular recurrence.

Exclusion Criteria

  • Have had another type of cancer within the last 5 years.
  • Have received chemotherapy or certain other cancer treatments recently (within the last 4 weeks to 3 months).
  • Have had radiotherapy within the last 12 weeks.
  • Have cancer that has spread outside the brain.
  • Are eligible for other ongoing studies with RZ-001 or have already received RZ-001 before.
  • Are currently part of another clinical study for which they are still eligible.

Locations

FACILITYZIPCITYSTATE
Brigham & Women's Hospital02115BostonMassachusetts

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