Experimental therapy aims to turn brain tumors against themselves
NCT ID NCT07826949
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are testing an experimental therapy called SRN-101 in adults with recurrent high-grade glioma, an aggressive brain cancer that has returned after standard treatment. Participants receive SRN-101 directly into the tumor before planned surgery to remove it. The trial's main goals are to check safety and measure how the therapy behaves in tumor tissue, blood, and spinal fluid. This is a first-in-human study with a very small number of participants, so it focuses on early safety and biological signals rather than proving effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SRN-101, an experimental therapy designed to destroy tumor cells and activate the immune system
- What this could lead to
- If SRN-101 proves safe and shows signs of attacking tumor cells, it could point toward a new treatment approach for recurrent high-grade glioma, a cancer with few options.
- What could go wrong
- This is a first-in-human Phase 1 trial with only 6 participants, so its main goal is to check safety, not to prove the treatment works. The therapy may cause serious side effects, fail to reach the tumor effectively, or show no benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female ≥ 18 years of age. 2. Participants have received at least one prior line of standard-of-care treatment for high-grade glioma (HGG). Specifically, participants have received prior surgery that resulted in histopathologic diagnosis followed by treatment with radiation alone and/or radiation plus temozolomide. 3. Participants with recurrent high-grade glioma (rHGG) for whom resection is planned, and with a lesion that is accessible to convection-enhanced delivery (CED) therapy. Eligible tumor types include central nervous system (CNS) World Health Organization (WHO) Grade 4 astrocytoma isocitrate dehydrogenase (IDH) wild-type (WT) (i.e., glioblastoma), WHO Grade 4 astrocytoma IDH mutated, WHO Grade 3 astrocytoma IDH WT or mutated, and WHO Grade 3 oligodendroglioma IDH mutated, 1p19q codeleted. Participants may have had multiple recurrences. 4. Tumors must be supratentorial in location, and participants can only have a single lesion that is ≥ 1 centimeter and ≤ 4 centimeters in diameter. 5. Performance Level using the Karnofsky score ≥ 70%. Note: Neurologic deficits in participants with CNS tumors must have been stable for at least 7 days with no new deficits prior to study enrollment. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the Karnofsky performance score. 6. Predictable life expectancy of at least 3 months. 7. Participants must have adequately recovered from the acute toxic effects of all prior anti-cancer chemotherapy and must be at least 3 weeks from previous cytotoxic chemotherapy, 4 weeks from prior radiation therapy, and at least 2 weeks from any major surgery, with evidence of adequate wound healing. 8. Participants must have adequate organ function based on laboratory assessments obtained within 21 days prior to study treatment. Laboratory values obtained as part of standard of care within this timeframe may be used to satisfy eligibility criteria. Adequate bone marrow function: absolute neutrophil count ≥1,500/microliter (mcL) platelets ≥100,000/mcL Adequate hepatic function: total bilirubin ≤ 2x upper limit of normal (ULN) for their age Aspartate aminotransferase (AST)serum glutamic-oxaloacetic transaminase (SGOT) ≤2 X institutional upper limit of normal alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) ≤2 X institutional upper limit of normal Serum albumin ≥ 2 g/dL Adequate renal function: creatinine ≤ 1.5 x within institutional upper limit of normal OR creatinine clearance radioisotope (GFR) ≥ 70 mL/min/1.73 m2, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2 Adequate coagulation: Prothrombin time and international normalized ratio ≤ 1.5x ULN Note: Participants receiving anticoagulant therapy must be able to safely discontinue anticoagulation per institutional guidelines and the treating neurosurgeon's discretion prior to infusion of SRN-101. 9. Participants with seizure disorders may be enrolled if on a stable anticonvulsant dose and not experiencing refractory seizures in the last 3 months. 10. Agree to participate in the long-term safety follow-up. 11. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Disseminated disease or multifocal disease. 2. Pregnant or breastfeeding. Participants of childbearing potential and male participants with female partners of childbearing potential must agree to always use highly effective forms of contraception during the course of the study and for at least 3 months after completion of study intervention. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Participants of childbearing potential must have a negative blood pregnancy test within 21 days of commencement of study intervention. Participants must refrain from donating sperm during the course of the study and for at least 3 months after completion of study intervention. 3. History of active liver disease, including Hepatitis B or Hepatitis C or human immunodeficiency virus (HIV). 4. Another concurrent tumor immunotherapy. 5. Initiation and/or escalation of systemic immunosuppressive therapy (including corticosteroids) within 7 days prior to study initiation, except protocol-required peri-procedural dexamethasone. Participants already on dexamethasone (at a maximum dose of 4 mg per day) are eligible. 6. Known or suspected hypersensitivity to Gadoteridol, its excipients, or other gadolinium-based contrast agents. 7. Recent onset of neurologic dysfunction or abnormality that is deemed by the Investigator to prevent patient participation. 8. Inability, or potential inability, to comply with the safety monitoring requirements of the study, as determined by the Investigator's opinion. 9. Other comorbidities that the Investigator believes will negatively impact the participant's ability to benefit from or tolerate this study. 10. Inability to undergo an MRI. 11. Radiographic evidence that the target lesion or an associated treatment or resection cavity directly communicates with the ventricular system, or determination by the treating neurosurgeon that adequate CED of the target lesion cannot be performed without clinically meaningful leakage of infusate into a cerebral spinal fluid (CSF) space.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of California, San Francisco
San Francisco, California, 94143, United States
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Other studies related to the condition(s) this trial covers.
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