A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) in Subjects with Glioblastoma

Launched by RZNOMICS, INC. · Oct 22, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called RZ-001, which is being tested alongside a medication called Valganciclovir (VGCV) for patients with glioblastoma, a type of brain cancer. The purpose of this study is to see how safe the combination is, how well it is tolerated by patients, and whether it shows any promising effects in fighting the cancer. The trial is currently recruiting participants aged 65 to 74 who have been diagnosed with a specific type of glioblastoma and have certain health conditions that make them eligible.

To join this study, participants need to be adults with a confirmed diagnosis of grade 4 glioblastoma, and they should have a specific marker (hTERT positive) in their tumors. They should also have a good level of functioning, meaning they can carry out daily activities with some assistance if needed. Those with other types of cancer, or certain health issues like HIV, may not be eligible. If someone joins the trial, they can expect regular monitoring by healthcare professionals and will contribute to important research that could help improve treatments for glioblastoma in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult males and females
• • Histologically-confirmed grade 4 astrocytoma, GBM, per The 2021 WHO Classification of CNS Tumors.
• • hTERT positive expression confirmed during the screening period
• • ECOG score of ≤ 2
• • KPS ≥ 60
• • Life expectancy ≥ 3 months
• Exclusion Criteria:
• • Diagnosis of other malignant tumors within 5 years prior to RZ-001 administration.
• • Have extracranial metastases of the tumor cells
• • Current or history of HIV positive
• • Not suitable for inclusion judged by the investigator