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

ConditionsRecurrent High-Grade GliomasBrain NeoplasmGlioma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNicholas Butowski

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • SRN-101

    Drug

    Given Intratumoral

  • Blood Specimen Collection

    Procedure/Surgery

    Perform blood work

  • Surgical Resection

    Procedure/Surgery

    Undergo surgery

  • Magnetic Resonance Imaging (MRI)

    Procedure/Surgery

    Undergo imaging

Treatment groups

6 Participants
are divided into 2 treatment groups
Group A: SRN-101 Run-in - Low Dose Level (First Participant)Experimental treatment 4 interventions
Group B: SRN-101 - High Dose Level (Subsequent Participants)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 21 days
2

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

Time frame
Up to 21 days
3

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.

Time frame
Up to 21 days
4

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.

Time frame
Up to 21 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nicholas Butowski

Lead sponsor

University of California, San Francisco

Sponsor institution

Siren Biotechnology

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: