Trial · NCT07902037
A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
NCT07902037, Phase 1, Phase 2, Not yet recruiting, Siren Biotechnology
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1). Trials, record NCT07902037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07902037
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
- NCT number
- NCT07902037
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Siren Biotechnology
- Conditions
- Recurrent High Grade Gliomas, Glioblastoma (GBM), Astrocytoma, Oligodendroglioma, Diffuse Hemispheric Glioma
- Interventions
- SRN-101
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation of the safety and tolerability of SRN-101 in adult participants with recurrent high-grade glioma. | From administration of SRN-101 through 12 months after treatment | 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. |
| Primary | Determination of the RP2D of SRN-101 | Through determination of the RP2D following completion of dose escalation, approximately 18 months | 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). |
| Secondary | Tumor response by Response Assessment in Neuro-Oncology (RANO) 2.0 | From baseline through disease progression or up to 12 months after SRN-101 administration | Tumor response will be assessed using RANO 2.0 criteria based on serial brain MRI and clinical status. |
| Secondary | Progression-free survival | Up to 12 months | Time from SRN-101 administration to disease progression or death, whichever occurs first. |
| Secondary | Clinical benefit rate | Through 6 months after SRN-101 administration | Description: Proportion of participants with complete response, partial response, or stable disease lasting 6 months. |
| Secondary | Overall survival | Up to 12 months | Time from SRN-101 administration to death from any cause. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42005833 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07902037
GET https://conductscience.org/api/trials/v1/NCT07902037/registered