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

Part of paid clinical trials in San Francisco, California.

Sponsor
Nicholas Butowski
Study ID
NCT07826949
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SRN-101 — DRUG
    Given Intratumoral
  • Blood Specimen Collection — PROCEDURE
    Perform blood work
  • Surgical Resection — PROCEDURE
    Undergo surgery
  • Magnetic Resonance Imaging (MRI) — PROCEDURE
    Undergo imaging

Study Details

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.

Key Dates

First listed
Sep 18, 2026
Start date
Oct 15, 2026
Status verified
Sep 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2031

Study Design

Enrollment
6 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SRN-101 Run-in Dose Level - 1.6E12 vg (First Participant)
    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.
  • Experimental: SRN-101 Dose Level - 5.0E12 vg (Subsequent Participants)
    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.

Primary Outcome Measure

Proportion of participants reporting treatment-emergent adverse events [ Time Frame: Up to 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Neuro-Oncology New Patient Coordinator
[email protected]
415-353-2193
Nicholas Butowski, MD (PRINCIPAL_INVESTIGATOR)

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