A Phase 1 Study of SRN-101 Administered Prior to Surgical Resection in Adults With Recurrent High-Grade Glioma.

NCT07826949 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 26104NCI-2026-06804
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent High-Grade Gliomas; Brain Neoplasm; Glioma

Keywords

Gene Therapy

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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.

  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.

  Up to 21 days

Study Arms (2)

SRN-101 Run-in Dose Level - 1.6E12 vg (First Participant)

EXPERIMENTAL

Participants will receive a single intratumoral administration of SRN-101 at a dose of 1.6E12 vector genomes (vg) via real-time MRI-guided convection-enhanced delivery (CED). Following administration, participants will be monitored for safety and tolerability through the day of tumor resection, which will take place 7 to 21 days after SRN-101 administration.

Drug: SRN-101; Procedure: Blood Specimen Collection; Procedure: Surgical Resection; Procedure: Magnetic Resonance Imaging (MRI)

SRN-101 Dose Level - 5.0E12 vg (Subsequent Participants)

EXPERIMENTAL

Participants will receive a single intratumoral administration of SRN-101 at a dose of 5.0E12 vector genomes (vg) via real-time MRI-guided convection-enhanced delivery (CED). Following administration, participants will be monitored for safety and tolerability through the day of tumor resection, which will take place 7 to 21 days after SRN-101 administration.

Drug: SRN-101; Procedure: Blood Specimen Collection; Procedure: Surgical Resection; Procedure: Magnetic Resonance Imaging (MRI)

Interventions

SRN-101 DRUG

Given Intratumoral

SRN-101 Dose Level - 5.0E12 vg (Subsequent Participants); SRN-101 Run-in Dose Level - 1.6E12 vg (First Participant)

Blood Specimen Collection PROCEDURE

Perform blood work

SRN-101 Dose Level - 5.0E12 vg (Subsequent Participants); SRN-101 Run-in Dose Level - 1.6E12 vg (First Participant)

Surgical Resection PROCEDURE

Undergo surgery

Also known as: Undergo surgical resection tumor tissue

SRN-101 Dose Level - 5.0E12 vg (Subsequent Participants); SRN-101 Run-in Dose Level - 1.6E12 vg (First Participant)

Magnetic Resonance Imaging (MRI) PROCEDURE

Undergo imaging

SRN-101 Dose Level - 5.0E12 vg (Subsequent Participants); SRN-101 Run-in Dose Level - 1.6E12 vg (First Participant)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Nicholas Butowski: lead
• Siren Biotechnology: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Interventions

Blood Specimen Collection; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Nicholas Butowski, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neuro-Oncology New Patient Coordinator

CONTACT

415-353-2193; neurooncnewpatientcoord@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 18, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2031
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)