A Phase 1/2 interventional study of SRN-101 in Recurrent High Grade Gliomas, Glioblastoma (GBM) and Astrocytoma, sponsored by Siren Biotechnology. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Siren Biotechnology · Phase 1/2, Interventional, and Treatment
ALERT-1 is a Phase 1/2 study evaluating the safety and preliminary anti-tumor activity of SRN-101, an investigational gene therapy, in adults with recurrent high-grade glioma. High-grade glioma is a type of brain cancer. This study is for adults whose cancer has returned for the first time and for whom surgical removal of the tumor is not planned.
SRN-101 uses an adeno-associated virus (AAV) to deliver a gene for human interferon beta, a protein within the tumor. The safety and effectiveness of SRN-101 in this setting have not been established.
Each participant will receive one infusion of SRN-101 directly into the brain tumor during an MRI-guided procedure. The study will first evaluate different dose levels and then evaluate a selected dose in additional participants.
Participants will have MRI scans, blood tests and other health assessments, and follow-up visits to assess safety and changes in their cancer.
ALERT-1 is a multicenter, open-label, Phase 1/2 study of SRN-101 in adults with recurrent high-grade glioma. SRN-101 is an investigational adeno-associated virus (AAV)-based gene therapy encoding an optimized human interferon beta (hIFNβ), intended to produce local hIFNβ expression within the tumor.
Each participant receives a single intratumoral infusion of SRN-101 using magnetic resonance imaging (MRI)-guided convection-enhanced delivery (CED).
Part 1 evaluates the safety and tolerability of different dose levels and identifies the Recommended Phase 2 Dose (RP2D). Part 2 further evaluates SRN-101 in an expansion cohort treated at the RP2D selected in Part 1.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's planned enrollment of 40 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →This is the only study on the registry with Siren Biotechnology as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant receives a single intratumoral infusion of SRN-101 using MRI-guided CED. In Part 1, successive cohorts receive different dose levels. In Part 2, participants receive the RP2D selected in Part 1.
Genetic: SRN-101
SRN-101 is an investigational AAV-based gene therapy encoding human interferon beta (hIFNβ). SRN-101 is administered as a single intratumoral infusion using MRI-guided CED.
Evaluation of the safety and tolerability of SRN-101 in adult participants with recurrent high-grade glioma.
Safety and tolerability will be assessed by the frequency and severity of study-related adverse events and serious adverse events (SAEs) through study period following administration of SRN-101. Adverse events will be graded according to the NCI CTCAE and summarized by relationship to SRN-101.
Time frame: From administration of SRN-101 through 12 months after treatment
Determination of the RP2D of SRN-101
The RP2D of SRN-101 will be determined based on the safety and tolerability of the dose levels evaluated during Part 1, including the occurrence of dose-limiting toxicities (DLTs). Dose-escalation decisions will be made by the Sponsor following review of available safety data and recommendations from the Data Safety Monitoring Board (DSMB).
Time frame: Through determination of the RP2D following completion of dose escalation, approximately 18 months
Tumor response by Response Assessment in Neuro-Oncology (RANO) 2.0
Tumor response will be assessed using RANO 2.0 criteria based on serial brain MRI and clinical status.
Time frame: From baseline through disease progression or up to 12 months after SRN-101 administration
Progression-free survival
Time from SRN-101 administration to disease progression or death, whichever occurs first.
Time frame: Up to 12 months
Clinical benefit rate
Description: Proportion of participants with complete response, partial response, or stable disease lasting 6 months.
Time frame: Through 6 months after SRN-101 administration
Overall survival
Time from SRN-101 administration to death from any cause.
Time frame: Up to 12 months
No study locations are listed for this record.
Plan to share: No
Start is estimated for Dec 2026; primary completion for Jan 2030, 37 months later.
Of 53 industry-sponsored phase 1/2 interventional studies under Glioblastoma, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 75. This study's planned 37 months is below that.
Counting every sponsor, half of 137 studies reached it within 66 months; a quarter within 45 and three quarters within 100.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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