Recurrent High-Grade GliomasPhase 1NCT07826949
A Study of SRN-101 Administered Prior to Surgical Resection in Adults With Recurrent High-Grade Glioma.
A Phase 1 study testing SRN-101, Blood Specimen Collection and Surgical Resection in people with Recurrent High-Grade Gliomas and Brain Neoplasm, run by Nicholas Butowski at 1 site in United States.
Trial summary
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 evaluate SRN-101 for the treatment of adults with recurrent high-grade glioma (rHGG) who are eligible for resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent High-Grade Gliomas, Brain Neoplasm, Glioma
- What is being tested?
- SRN-101, Blood Specimen Collection and Surgical Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2026to 31 Jan 2032
- Phase
- Phase 1
- 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
- Male or female ≥ 18 years of age.
- 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.
- 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.
- Tumors must be supratentorial in location, and participants can only have a single lesion that is ≥ 1 centimeter and ≤ 4 centimeters in diameter.
- 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.
- Predictable life expectancy of at least 3 months.
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- 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.
- 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.
- Participants with seizure disorders may be enrolled if on a stable anticonvulsant dose and not experiencing refractory seizures in the last 3 months.
- Agree to participate in the long-term safety follow-up.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Disseminated disease or multifocal disease.
- 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.
- History of active liver disease, including Hepatitis B or Hepatitis C or human immunodeficiency virus (HIV).
- Another concurrent tumor immunotherapy.
- 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.
- Known or suspected hypersensitivity to Gadoteridol, its excipients, or other gadolinium-based contrast agents.
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- Recent onset of neurologic dysfunction or abnormality that is deemed by the Investigator to prevent patient participation.
- Inability, or potential inability, to comply with the safety monitoring requirements of the study, as determined by the Investigator's opinion.
- Other comorbidities that the Investigator believes will negatively impact the participant's ability to benefit from or tolerate this study.
- Inability to undergo an MRI.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
Neuro-Oncology New Patient Coordinator, 415-353-2193, neurooncnewpatientcoord@ucsf.edu
Nicholas Butowski, MD
About this study
Official title: A Phase 1 Window-of-Opportunity Study of SRN-101 Administered Prior to Surgical Resection in Adults With Recurrent High-Grade Glioma.
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 evaluate SRN-101 for the treatment of adults with recurrent high-grade glioma (rHGG) who are eligible for resection.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and tolerability of intratumoral administration of SRN-101 in participants with recurrent high-grade glioma (rHGG) undergoing resection.
II. To evaluate the biologic activity of SRN-101.
EXPOLORATORY OBJECTIVES:
- To assess immunologic response to SRN-101. II. To identify potential pharmacodynamics biomarkers for SRN-101 activity.
OUTLINE: Participants will receive a single administration of SRN-101 during real-time magnetic resonance imaging (MRI)-guided convection-enhanced delivery (CED), followed by non-investigational surgical resection 7 to 21 days after SRN-101 administration. Participants will be followed for up to 5 years after surgical resection.
- Conditions
- Recurrent High-Grade Gliomas, Brain Neoplasm, Glioma
- Being tested
- SRN-101, Blood Specimen Collection, Surgical Resection, Magnetic Resonance Imaging (MRI)
- Keywords
- Gene Therapy
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRN-101Drug
Given Intratumoral
Blood Specimen CollectionProcedure or surgery
Perform blood work
Surgical ResectionProcedure or surgery
Also called Undergo surgical resection tumor tissue
Undergo surgery
Magnetic Resonance Imaging (MRI)Procedure or surgery
Undergo imaging
| Study group | Role | What they receive |
|---|---|---|
| SRN-101 Run-in - Low Dose Level (First Participant) | Experimental | Participants will receive a single low-dose intratumoral administration of SRN-101 via real-time MRI-guided convection-enhanced delivery (CED). Following administration, participants will be monitored for safety and tolerability through Day 21, even if tumor resection occurs earlier. Tumor resection will take place 7 to 21 days after SRN-101 administration. Receives: Drug: SRN-101; Procedure: Blood Specimen Collection; Procedure: Surgical Resection; Procedure: Magnetic Resonance Imaging (MRI) |
| SRN-101 - High Dose Level (Subsequent Participants) | Experimental | Participants will receive a single intratumoral administration of SRN-101 at a high dose via real-time MRI-guided convection-enhanced delivery (CED). Following administration, participants will be monitored for safety and tolerability through Day 21, even if tumor resection occurs earlier. Tumor resection will take place 7 to 21 days after SRN-101 administration. Receives: Drug: SRN-101; Procedure: Blood Specimen Collection; Procedure: Surgical Resection; Procedure: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants reporting treatment-emergent adverse events
Treatment-emergent adverse events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Measured: Up to 21 days
Proportion of participants reporting adverse events of special interest
Adverse events of special interest (AESI) will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Measured: Up to 21 days
Quantification of SRN-101 vector copy number
SRN-101 vector copy number will be measured in resected tumor tissue, peripheral blood, and cerebrospinal fluid (if available) using quantitative polymerase chain reaction (qPCR). Results will be summarized descriptively.
Measured: Up to 21 days
Quantification of hIFNβ transcript and protein levels
hIFNβ transcript and protein levels will be measured in resected tumor tissue, peripheral blood, and cerebrospinal fluid (CSF; if available) using reverse transcription quantitative polymerase chain reaction (RT-qPCR) and enzyme-linked immunosorbent assay (ELISA), respectively. Results will be summarized descriptively.
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start15 Nov 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent High-Grade GliomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicholas Butowski
- Sponsor type
- University, hospital or other
- Collaborators
- Siren Biotechnology
- Responsible party
- Sponsor-investigator, Nicholas Butowski, University of California, San Francisco
- Investigators
- Nicholas Butowski, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826949
- Sponsor's protocol ID
- 26104
- Other IDs
- NCI-2026-06804
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Window-of-Opportunity Study of SRN-101 Administered Prior to Surgical Resection in Adults With Recurrent High-Grade Glioma.
- ClinicalTrials.gov ID
- NCT07826949
- Acronym / sponsor ID
- 26104
- Conditions
- Recurrent High-Grade Gliomas, Brain Neoplasm, Glioma
- Keywords
- Gene Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Nicholas ButowskiUniversity, hospital or other
- Collaborators
- Siren Biotechnology
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jan 2032 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 evaluate SRN-101 for the treatment of adults with recurrent high-grade glioma (rHGG) who are eligible for resection.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and tolerability of intratumoral administration of SRN-101 in participants with recurrent high-grade glioma (rHGG) undergoing resection.
II. To evaluate the biologic activity of SRN-101.
EXPOLORATORY OBJECTIVES:
- To assess immunologic response to SRN-101. II. To identify potential pharmacodynamics biomarkers for SRN-101 activity.
OUTLINE: Participants will receive a single administration of SRN-101 during real-time magnetic resonance imaging (MRI)-guided convection-enhanced delivery (CED), followed by non-investigational surgical resection 7 to 21 days after SRN-101 administration. Participants will be followed for up to 5 years after surgical resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRN-101 Run-in - Low Dose Level (First Participant) | Experimental | Drug: SRN-101, Procedure: Blood Specimen Collection, Procedure: Surgical Resection, Procedure: Magnetic Resonance Imaging (MRI)Participants will receive a single low-dose intratumoral administration of SRN-101 via real-time MRI-guided convection-enhanced delivery (CED). Following administration, participants will be monitored for safety and tolerability through Day 21, even if tumor resection occurs earlier. Tumor resection will take place 7 to 21 days after SRN-101 administration. |
| SRN-101 - High Dose Level (Subsequent Participants) | Experimental | Drug: SRN-101, Procedure: Blood Specimen Collection, Procedure: Surgical Resection, Procedure: Magnetic Resonance Imaging (MRI)Participants will receive a single intratumoral administration of SRN-101 at a high dose via real-time MRI-guided convection-enhanced delivery (CED). Following administration, participants will be monitored for safety and tolerability through Day 21, even if tumor resection occurs earlier. Tumor resection will take place 7 to 21 days after SRN-101 administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male or female ≥ 18 years of age.
- 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.
- 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.
- Tumors must be supratentorial in location, and participants can only have a single lesion that is ≥ 1 centimeter and ≤ 4 centimeters in diameter.
- 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.
Key exclusion criteria (11 listed)
- Disseminated disease or multifocal disease.
- 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.
- History of active liver disease, including Hepatitis B or Hepatitis C or human immunodeficiency virus (HIV).
- Another concurrent tumor immunotherapy.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRN-101Given Intratumoral | Drug | SRN-101 - High Dose Level (Subsequent Participants), SRN-101 Run-in - Low Dose Level (First Participant) |
| Blood Specimen CollectionPerform blood work | Procedure or surgery | SRN-101 - High Dose Level (Subsequent Participants), SRN-101 Run-in - Low Dose Level (First Participant) |
| Surgical ResectionAlso: Undergo surgical resection tumor tissueUndergo surgery | Procedure or surgery | SRN-101 - High Dose Level (Subsequent Participants), SRN-101 Run-in - Low Dose Level (First Participant) |
| Magnetic Resonance Imaging (MRI)Undergo imaging | Procedure or surgery | SRN-101 - High Dose Level (Subsequent Participants), SRN-101 Run-in - Low Dose Level (First Participant) |
Primary outcome
Proportion of participants reporting treatment-emergent adverse events
Time frame: Up to 21 days
Treatment-emergent adverse events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Proportion of participants reporting adverse events of special interest
Time frame: Up to 21 days
Adverse events of special interest (AESI) will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Quantification of SRN-101 vector copy number
Time frame: Up to 21 days
SRN-101 vector copy number will be measured in resected tumor tissue, peripheral blood, and cerebrospinal fluid (if available) using quantitative polymerase chain reaction (qPCR). Results will be summarized descriptively.
Quantification of hIFNβ transcript and protein levels
Time frame: Up to 21 days
hIFNβ transcript and protein levels will be measured in resected tumor tissue, peripheral blood, and cerebrospinal fluid (CSF; if available) using reverse transcription quantitative polymerase chain reaction (RT-qPCR) and enzyme-linked immunosorbent assay (ELISA), respectively. Results will be summarized descriptively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Butowski, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SRN-101, Blood Specimen Collection and Surgical Resection in people with Recurrent High-Grade Gliomas and Brain Neoplasm, run by Nicholas Butowski 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 20 inclusion and 11 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 27 Oct 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 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.
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 Neuro-Oncology New Patient Coordinator (415-353-2193, neurooncnewpatientcoord@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants reporting treatment-emergent adverse events (time frame: Up to 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.