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High Grade GliomaPhase 2NCT06264388

DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma

A Phase 2 study testing DB107-RRV and DB107-FC in people with High Grade Glioma and Anaplastic Astrocytoma, run by Ashish Shah at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
High Grade Glioma, Anaplastic Astrocytoma
What is being tested?
DB107-RRV and DB107-FC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
1 May 2024to 1 May 2034
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • History of active other malignancy (other than non-melanoma skin cancers, cervical ductal carcinoma in situ or localized prostate cancer) within 5 years.
  • Multifocal gliomas that cannot undergo stereotactic biopsy/administration of DB107-RRV will be excluded. Patients with 3 or more intracranial recurrences will be excluded.
  • Histologically confirmed oligodendroglioma or mixed gliomas.
  • History of human immunodeficiency virus (HIV) infection or other forms of severe immunosuppression.
  • Patients with impaired renal function (eGFR<50 cc/min).
  • Patients with bone marrow depression, such as those with a hematological disease or who are being treated with radiation or drugs that depress bone marrow or individuals who have a history of treatment with drugs or radiation that depress bone marrow within 1 month of enrollment.
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  • The patient intends to undergo treatment with the Gliadel® wafer at the time of this surgery or has received the Gliadel® wafer < 30 days from surgery.
  • Allergy to 5-FC.
  • Gastrointestinal diseases that prevent absorption of medications such as 5-FC.
  • Pregnancy or patients who are actively breast-feeding.
  • Recent use of cytosine arabinoside (< 3 weeks).
  • Recent treatment with bevacizumamab (< 3 weeks).
  • Recent treatment with temozolomide (<4 weeks).
  • History of bleeding diathesis or current anti-coagulant or anti-platelet usage, including nonsteroidal anti-inflammatory drugs (NSAIDs), at the time of the scheduled resection that cannot be stopped for surgery.
  • Sustained dependence on systemic dexamethasone (>8 mg/day) one month prior to surgery.
  • Severe systemic illnesses including cardiopulmonary dysfunction (New York Heart Association > Grade 2 congestive heart failure (CHF), uncontrolled arrhythmias, significant pulmonary disease > Grade 2 dyspnea) or other serious medical condition or social situations that in the judgement of the Investigator(s) would interfere or limit compliance with study requirements/treatments.
  • The patient has or had any active infection requiring systemic antibiotic, antifungal or antiviral therapy within the past 4 weeks.
  • Current or active coronavirus disease (COVID-19) disease, positive quantitative polymerase chain reaction (qPCR) result.
  • Patients with impaired decision-making capacity.
  • Patients who are currently receiving investigational medications or medical device(s) within 4 weeks (or 5 half-lives of the investigational medication(s), whichever is shorter) prior to enrollment.
  • Patients who have any other disease, either metabolic or psychological, which as per Investigator assessment may affect the patient's compliance or place the patient at higher risk of potential treatment complications.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Leonela Wright, MSN, RN contact

305-243-0864

lxw612@med.miami.edu

Ashish Shah, MD contact

3052436946

ashah@med.miami.edu

United States1 site, 1 recruiting

  • University of Miami Hospital

    Miami, Florida, 33136

    Leonela Wright, MSN, RN, 305-243-0864, lxw612@med.miami.edu

    Ashish Shah, MD, 305-243-6946, ashah@med.miami.edu

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Being tested
DB107-RRV, DB107-FC
Medical subject headings
Glioma, Astrocytoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DB107-RRVDrug

    Patients will undergo surgery to remove as much of the high-grade glioma (HHG) tumor as possible and will receive combination intravenous (IV) and adaptive repeat intratumoral delivery of DB107-RRV in the vein (IV) and in the walls of the cavity that remains where tumor is removed.

  • DB107-FCDrug

    Also called Ancobon, Ancotil

    Patients will start taking DB107-FC three times by mouth every day for a period of seven days, which is one cycle of treatment. A cycle of treatment is medication taken on a set schedule with periods of rest in between. Patients will wait five weeks before taking the next seven day course of DB107-FC. The first dose of DB107-FC will be taken at the hospital or clinic; afterward, patients will take the doses of DB107-FC at home. Patients will take DB107-FC for up to 12 months after surgery.

Study groups in NCT06264388
Study groupRoleWhat they receive
DB107-RRV and DB107-FC GroupExperimentalPatients 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.
Receives: Drug: DB107-RRV; Drug: DB107-FC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Progression free survival (PFS) is defined as duration from initiation of treatment to the point of disease progression or death.

    Measured: Up to 24 Months

  2. Overall Survival

    Overall survival (OS) refers to the duration from the initiation of enrollment until death, regardless of the cause.

    Measured: Up to 24 Months

Secondary outcomes (5)

  1. Assessment of Tumor Status Measured by Response Assessment in Neuro-oncology (RANO) Criteria

    To evaluate the radiological response in participants with recurrent HGG based on overall response (CR) or partial response (PR), stable disease (SD), and progressive disease (PD) per the Response Assessment in Neuro-oncology (RANO) criteria.

    Measured: Up to 5 Years

  2. Number of Treatment Related Toxicities

    Number of treatment related toxicities will be assessed by the development of treatment-related ≥ Grade 3 adverse events as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

    Measured: Up to 5 Years

  3. Durable Response Rate (DRR)

    Durable response rate (DRR) is defined as the proportion of patients whose best response to treatment is either complete response (CR) or partial response (PR) lasting at least 24 weeks as evidenced by MRI. DDR is calculated as the total number of patients with CR or PR lasting at least 24 weeks.

    Measured: Up to 5 Years

  4. Durable Clinical Benefit Rate (DCBR)

    Durable clinical benefit rate (DCBR) is defined as the proportion of patients whose best overall response is either CR or PR lasting at least 24 weeks or SD lasting at least 12 months according to modified RANO criteria as evidenced by MRI imaging. Durable clinical benefit rate is calculated as the total number of patients with CR or PR ≥ 24 weeks or with SD > 12 months.

    Measured: Up to 5 Years

  5. Duration of Durable Response Rate

    Duration of durable response (DDR) is the tabulation of the total number of patients with CR, PR, SD, and PD at 12 months after surgery.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start1 May 2024
  3. Primary completion1 May 2034 (estimated)
  4. Study completion1 May 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06264388
Sponsor's protocol ID
20231234
Other IDs
R21CA282543
Status last verified
May 2026
First submitted
8 Feb 2024
Last updated
28 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DB107-RRV and DB107-FC in people with High Grade Glioma and Anaplastic Astrocytoma, run by Ashish Shah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leonela Wright, MSN, RN (305-243-0864, lxw612@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Up to 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06264388.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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