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Recurrent High Grade GliomasPhase 1/2ALERT-1NCT07902037

A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)

A Phase 1/2 study testing SRN-101 in people with Recurrent High Grade Gliomas and Glioblastoma (GBM), run by Siren Biotechnology.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

ALERT-1 is a Phase 1/2 study evaluating the safety and preliminary anti-tumor activity of SRN-101, an investigational gene therapy, in adults with recurrent high-grade glioma. High-grade glioma is a type of brain cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SRN-101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Dec 2026to Jan 2030
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • First recurrence of high-grade glioma for which surgical resection is not planned
  • Eligible tumor type, including Grade 3 or Grade 4 astrocytoma, Grade 3 oligodendroglioma, glioblastoma, or diffuse hemispheric glioma, with histologic confirmation of malignancy
  • Received prior standard treatment for high-grade glioma, including surgery followed by radiation alone or radiation with temozolomide
  • A single tumor located above the tentorium that is accessible for treatment with SRN-101 and is 1 to 4 centimeters in diameter
  • Karnofsky performance status of at least 70%
  • Life expectancy of at least 3 months
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  • Recovered from the acute effects of prior anti-cancer treatment and meets required waiting periods following prior chemotherapy, radiation therapy, and major surgery
  • Adequate bone marrow, kidney, liver, and blood-clotting function
  • Willing to participate in the long-term safety follow-up study

Who cannot join

  • Disseminated or multifocal disease
  • Pregnant or breastfeeding
  • History of or current liver disease, including active hepatitis B or hepatitis C, or human immunodeficiency virus
  • Receiving another tumor immunotherapy
  • Recent initiation or increase in systemic immunosuppressive therapy, including corticosteroids, except as permitted by the protocol
  • Recent neurologic dysfunction or abnormality that, in the Investigator's judgment, would prevent participation
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  • Unable to comply with the study's safety monitoring requirements
  • Other medical conditions that, in the Investigator's judgment, could negatively affect the participant's ability to benefit from or tolerate the study
  • Unable to undergo magnetic resonance imaging (MRI)

About this study

Official title: A Phase 1/2, Dose-Escalation and Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of SRN-101, a Recombinant Adeno-Associated Virus Immunotherapy in Adults With Recurrent High-Grade Glioma

ALERT-1 is a Phase 1/2 study evaluating the safety and preliminary anti-tumor activity of SRN-101, an investigational gene therapy, in adults with recurrent high-grade glioma. High-grade glioma is a type of brain cancer. This study is for adults whose cancer has returned for the first time and for whom surgical removal of the tumor is not planned.

SRN-101 uses an adeno-associated virus (AAV) to deliver a gene for human interferon beta, a protein within the tumor. The safety and effectiveness of SRN-101 in this setting have not been established.

Read more

Each participant will receive one infusion of SRN-101 directly into the brain tumor during an MRI-guided procedure. The study will first evaluate different dose levels and then evaluate a selected dose in additional participants.

Participants will have MRI scans, blood tests and other health assessments, and follow-up visits to assess safety and changes in their cancer.

Read the detailed description

ALERT-1 is a multicenter, open-label, Phase 1/2 study of SRN-101 in adults with recurrent high-grade glioma. SRN-101 is an investigational adeno-associated virus (AAV)-based gene therapy encoding an optimized human interferon beta (hIFNβ), intended to produce local hIFNβ expression within the tumor.

Each participant receives a single intratumoral infusion of SRN-101 using magnetic resonance imaging (MRI)-guided convection-enhanced delivery (CED).

Part 1 evaluates the safety and tolerability of different dose levels and identifies the Recommended Phase 2 Dose (RP2D). Part 2 further evaluates SRN-101 in an expansion cohort treated at the RP2D selected in Part 1.

Being tested
SRN-101
Keywords
Gene therapy, Interferon beta, Intratumoral therapy, Convection-enhanced delivery, ALERT-1, SRN-101, Adeno-associated virus
Medical subject headings
Glioblastoma, Astrocytoma, Oligodendroglioma

What participants receive

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

  • SRN-101Genetic

    SRN-101 is an investigational AAV-based gene therapy encoding human interferon beta (hIFNβ). SRN-101 is administered as a single intratumoral infusion using MRI-guided CED.

Study groups in NCT07902037
Study groupRoleWhat they receive
SRN-101 treatmentExperimentalEach participant receives a single intratumoral infusion of SRN-101 using MRI-guided CED. In Part 1, successive cohorts receive different dose levels. In Part 2, participants receive the RP2D selected in Part 1.
Receives: Genetic: SRN-101

What is being measured

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

  1. Evaluation of the safety and tolerability of SRN-101 in adult participants with recurrent high-grade glioma.

    Safety and tolerability will be assessed by the frequency and severity of study-related adverse events and serious adverse events (SAEs) through study period following administration of SRN-101. Adverse events will be graded according to the NCI CTCAE and summarized by relationship to SRN-101.

    Measured: From administration of SRN-101 through 12 months after treatment

  2. Determination of the RP2D of SRN-101

    The RP2D of SRN-101 will be determined based on the safety and tolerability of the dose levels evaluated during Part 1, including the occurrence of dose-limiting toxicities (DLTs). Dose-escalation decisions will be made by the Sponsor following review of available safety data and recommendations from the Data Safety Monitoring Board (DSMB).

    Measured: Through determination of the RP2D following completion of dose escalation, approximately 18 months

Secondary outcomes (4)

  1. Tumor response by Response Assessment in Neuro-Oncology (RANO) 2.0

    Tumor response will be assessed using RANO 2.0 criteria based on serial brain MRI and clinical status.

    Measured: From baseline through disease progression or up to 12 months after SRN-101 administration

  2. Progression-free survival

    Time from SRN-101 administration to disease progression or death, whichever occurs first.

    Measured: Up to 12 months

  3. Clinical benefit rate

    Description: Proportion of participants with complete response, partial response, or stable disease lasting 6 months.

    Measured: Through 6 months after SRN-101 administration

  4. Overall survival

    Time from SRN-101 administration to death from any cause.

    Measured: Up to 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 posted28 Oct 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionJan 2030 (estimated)
  4. Study completionJan 2030 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
The study has two sequential parts. Part 1 includes a safety run-in and dose-escalation cohorts, with protocol-specified review of available safety data. Part 2 is an expansion cohort treated at the RP2D selected in Part 1.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07902037
Sponsor's protocol ID
SRN-101-1001
Acronym
ALERT-1
Status last verified
Oct 2026
First submitted
14 Oct 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kuwahara A, Fenton EM, Lovejoy C, Lee T, Wang L, Fogarty M, Jung J, Guo SM, Maynard LH, May AP, Rossenberg-Hasson Y, Clarke JL, Diaz AA, Phillips JJ, Kelly L, Clement N, Paulk NK. AAV immuno-gene therapy platform delivering vectorized cytokines defines a new modality for high-grade glioma treatment. Mol Ther Oncol. 2026 Mar 20;34(2):201183. doi: 10.1016/j.omton.2026.201183. eCollection 2026 Jun 18.

    PubMed 42005833

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SRN-101 in people with Recurrent High Grade Gliomas and Glioblastoma (GBM), run by Siren Biotechnology.

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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the safety and tolerability of SRN-101 in adult participants with recurrent high-grade glioma. (time frame: From administration of SRN-101 through 12 months after treatment). 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 NCT07902037, which also lists 1 linked publication.

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 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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