SRN-101 for Brain Cancer

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Overseen ByNeuro-Oncology New Patient Coordinator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores SRN-101, a new treatment for brain cancer designed to eliminate tumor cells and boost the immune system to combat the cancer. It targets adults with recurrent high-grade glioma, an aggressive brain tumor, who are planning to undergo surgery. Participants should have previously received standard treatments for their condition and have a tumor suitable for the study's method. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulant therapy, you must be able to safely stop it before receiving SRN-101. Also, if you are on corticosteroids, you should not increase the dose within 7 days before starting the study, except for a specific dose of dexamethasone.

Is there any evidence suggesting that SRN-101 is likely to be safe for humans?

Research shows that SRN-101 remains in the early stages of testing to determine its safety for people. In similar early studies on new brain cancer treatments, patients usually tolerate the treatments well, although some side effects can occur.

The FDA has granted SRN-101 Fast Track status, indicating its potential for treating recurring high-grade glioma. However, specific information about side effects in humans is not yet available. Early trials like this one primarily focus on ensuring the treatment does not cause serious harm and is safe enough for further research. Participants in this trial will receive either a low or high dose of SRN-101, and researchers will closely monitor their health after treatment.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for brain cancer, which often involve surgery, radiation, and chemotherapy, SRN-101 offers a novel approach by delivering the drug directly into the tumor using real-time MRI-guided convection-enhanced delivery (CED). This method allows for precise targeting of the cancer cells, potentially increasing the effectiveness of the treatment while minimizing damage to surrounding healthy tissue. Researchers are particularly excited about SRN-101 because this targeted delivery method could lead to improved safety and tolerability, crucial factors for patients undergoing brain cancer treatment.

What evidence suggests that SRN-101 might be an effective treatment for brain cancer?

Research has shown that SRN-101 may help treat recurrent high-grade glioma, a severe type of brain cancer. Studies suggest that SRN-101 can kill cancer cells and strengthen the immune system to combat the disease. Early lab results indicate that SRN-101 can generate a strong response against tumors, offering a new approach to these difficult-to-treat cancers. In this trial, participants will receive SRN-101 at either a low or high dose, administered via real-time MRI-guided convection-enhanced delivery. Although research in humans is ongoing, this treatment employs advanced gene therapy to target and destroy cancer cells, providing hope for better outcomes.678910

Who Is on the Research Team?

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Nicholas Butowski, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults with recurrent high-grade glioma (a type of aggressive brain tumor) who are eligible for surgery to remove the tumor. Participants must be able to safely undergo surgery and meet other health requirements set by the study team.

Inclusion Criteria

I understand the study and am willing to sign a consent form.
Predictable life expectancy of at least 3 months
I have controlled seizures and my medication dose has not changed recently.
See 8 more

Exclusion Criteria

I am currently receiving immunotherapy for my tumor.
Inability or potential inability to comply with safety monitoring requirements as determined by Investigator
My disease has spread to multiple areas in my body.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intratumoral administration of SRN-101 via real-time MRI-guided convection-enhanced delivery (CED)

1 day
1 visit (in-person)

Surgical Resection

Participants undergo non-investigational surgical resection 7 to 21 days after SRN-101 administration

7-21 days
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • SRN-101

Trial Overview

The study tests a new drug, SRN-101, given before planned brain tumor surgery. Researchers will monitor how well it works and its safety using blood tests and MRI scans. All participants receive SRN-101; there is no comparison group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: SRN-101 Run-in - Low Dose Level (First Participant)Experimental Treatment4 Interventions
Group II: SRN-101 - High Dose Level (Subsequent Participants)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nicholas Butowski

Lead Sponsor

Trials
3
Recruited
130+

Siren Biotechnology

Industry Sponsor

Citations

FDA Clears Investigator-Initiated IND for SRN-101 in ...

median overall survival for newly diagnosed patients remains approximately 15 to 20 months.

Siren Biotechnology Receives FDA Fast Track Designation ...

SRN-101, enabling first-in-human clinical evaluation in patients with recurrent high-grade glioma. potent anti-tumor immune response within the ...

UCSF Glioma Trial → SRN-101 Administered Prior to ...

SRN-101 is designed to destroys tumor cells while simultaneously activating the immune system to fight cancer. This is a first in human, single arm study to ...

Development of an AAV gene therapy immunotherapy for the ...

The 5-year survival rate is 5%. Here, AAVs deliver cytokines with potent anti-tumor activity.

AAV immuno-gene therapy platform delivering vectorized ...

Collectively, these results establish SRN-101 as a potent, manufacturable, and clinically translatable AAV immuno-gene therapy with robust efficacy in rigorous ...

Next-Generation Therapeutics | February Round-Up 2026

Siren Biotechnology said the FDA granted Fast Track designation to SRN-101, its AAV-based immuno-gene therapy for recurrent high-grade glioma.

Evaluation of the Safety and Benefit of Phase I Oncology Trials ...

We compared outcomes to pooled analysis of published studies in solid tumors with various molecular and cytotoxic drugs evaluated as single ...

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ucla.clinicaltrials.researcherprofiles.org

ucla.clinicaltrials.researcherprofiles.org/brain-cancer

UCLA Brain Cancer Clinical Trials for 2026 — Los Angeles

This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine

FDA Grants Fast Track Designation to Siren ...

The FDA has granted #FastTrack Designation to SRN-101, our lead Universal AAV Immuno-Gene Therapy candidate for recurrent high-grade glioma.

FDA Grants Orphan Drug Designation to TTX101 in ...

TTX101 given as an intracranial injection successfully led to a reduction in tumor volume.3 There were also no significant changes or evidence ...