Study on DB107-RRV, DB107-FC, and Radiation Therapy with or Without Temozolomide for High Grade Glioma

Sponsor: University of California, San Francisco

Sponsor score: 40

ClinicalTrials ID:NCT06504381

This clinical trial is testing a new treatment approach for patients with newly diagnosed High Grade Glioma (HGG), a type of brain cancer. The study aims to see if adding the experimental drugs DB107-RRV and DB107-FC to standard treatments can provide better outcomes.

Patient Parameters

Parameter	Options

Program Overview

The study is exploring whether the combination of two experimental drugs, DB107-RRV and DB107-FC, with standard treatments can improve outcomes for patients with newly diagnosed High Grade Glioma (HGG). Patients will undergo surgery to remove as much of the tumor as possible, followed by radiation therapy and, for some, the chemotherapy drug Temozolomide. The study will compare the results to past clinical trials to see if this new approach offers any benefits.

Description

The main goals of this study are to determine the safety and effectiveness of the experimental drugs DB107-RRV and DB107-FC when used with standard treatments for High Grade Glioma (HGG). In the first phase, researchers will focus on the safety of these drugs when given directly into the brain and through an IV after surgery. In the second phase, they will look at how well the treatment works in stopping the cancer from growing and improving survival rates.

Participants will first receive the experimental drugs during surgery and then continue with radiation therapy and possibly Temozolomide, depending on their specific cancer type. The study will monitor how well the treatment works in shrinking the tumor and improving survival, as well as any side effects. Participants will be followed for up to 15 years to gather long-term data on the treatment's effectiveness and safety.

Eligibility Criteria

Inclusion Criteria

Must be between 18 and 75 years old.
Must have a newly diagnosed High Grade Glioma (HGG) that has not been treated before.
Must be able to have at least 80% of the tumor removed by surgery.
Must agree to provide a blood sample and tumor tissue for testing.
Must have good overall health and organ function as shown by specific blood tests.
Women of childbearing age and men must agree to use effective birth control during the study and for 90 days after treatment.
Must not be breastfeeding.
Must be willing to follow the study schedule and procedures.

Exclusion Criteria

Have had previous treatment for High Grade Glioma.
Have another type of cancer unless it has been treated and disease-free for at least 5 years.
Have a specific type of brain tumor called oligodendroglioma.
Have a brain tumor that is too large or has spread to other areas.
Have an active infection requiring treatment within 4 weeks before starting the study.
Need to take blood thinners or certain medications that cannot be stopped for surgery.
Have HIV, Hepatitis B, or Hepatitis C.
Have an allergy to the study drug DB107-FC.
Have a condition that prevents swallowing or absorbing the study drug.
Plan to use the Gliadel® wafer during surgery.
Have severe heart, lung, or other health issues that prevent surgery.
Have any other condition that may affect participation or increase risk during the study.

Locations

FACILITY	ZIP	CITY	STATE
University of Southern California	90089	Los Angeles	California
University of California, San Diego	92093	San Diego	California
University of California	94143	San Francisco	California

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