A Biomarker-Guided Phase 2 Study of DB107-RRV (Retroviral Replicating Vector) Combined With DB107-Flucytosine Extended-Release Tablets in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to determine if the investigational products, DB107-RRV and DB107-FC, as a combination treatment will shrink high-grade glioma (HGG) in patients with recurrent/progressive, resectable or unresectable disease and increase the time that disease is controlled.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Patients 18-75 years old.

• Histologically proven HGG that have recurred/progressed (first or second recurrence).

• Patients with unresectable or resectable HGG (AA or GBM) will be enrolled.

• Measurable disease on MRI as evidenced by 1 cm on two separate dimensions on MRI fluid attenuated inversion recovery (FLAIR) (non-enhancing) or contrast-enhancement.

• Last temozolomide dosage 4 weeks prior to surgery.

• Patients with prior radiation therapy are allowed, but histological tumor diagnosis of recurrent tumor must be confirmed according to the RANO criteria. Recurrence must be confirmed by diagnostic biopsy with local pathology review or contrast-enhanced MRI. If first recurrence of GBM is documented by MRI, an interval of at least 12 weeks after the end of prior radiation therapy is required unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field.

• Presence of Denovo Genomic Marker 7 (DGM7) biomarker in blood.

• Laboratory values (Platelet count ≥ 80,000, hemoglobin \[Hg\] ≥10 g/dL, absolute neutrophil count (ANC) \> 1,500 cells/mm3, absolute lymphocyte count (ALC) \> 500/mm3) and adequate liver function, total bilirubin\< 1.5 upper limit of normal (ULN), alanine transaminase (ALT) \<2.5 ULN. Estimated glomerular filtration rate (eGFR) should be \> 50 mL/min (Cockcroft Gault Formula). Patients with aspartate transaminase (AST) or ALT values \>3 ULN and total bilirubin \>1.5 mg/dL will be excluded.

• Patients cannot be pregnant at the time of enrollment or during the study. Patients willing to use one (1) effective method of contraception in addition to barrier methods (condoms) from the time of signing the informed consent form until 12 months after receiving the last dose of DB107-RRV or until there is no evidence of DB107-RRV in their blood, whichever is longer.

⁃ Karnofsky Performance Score (KPS) ≥ 70.

⁃ Patient is able to consent and abide by protocol.

Locations
United States
Florida
University of Miami Hospital
RECRUITING
Miami
Contact Information
Primary
Leonela Wright, MSN, RN
lxw612@med.miami.edu
305-243-0864
Backup
Ashish Shah, MD
ashah@med.miami.edu
3052436946
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2034-05-01
Participants
Target number of participants: 33
Treatments
Experimental: DB107-RRV and DB107-FC Group
Patients will receive DB107-RRV during the tumor resection/biopsy procedure. Approximately 6 weeks after surgery, patients will start drug therapy with a 7-day oral regimen of 220 mg/kg/day DB107-FC, which is to be self-administered. This 7-day regimen, which is considered one cycle of treatment, is to be repeated every 6 weeks for up to 12 months. Patients will undergo follow up procedures for at least 5 years after last DB107-RRV treatment.
Sponsors
Collaborators: Denovo Biopharma LLC, National Cancer Institute (NCI)
Leads: Ashish Shah

This content was sourced from clinicaltrials.gov

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