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NCT05736406 · ClinicalTrials.gov registry record · Phase 1
A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma
A Phase 1 study of Primary Glioblastoma, sponsored by Hemerion Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT05736406 is a Phase 1 study of Primary Glioblastoma that is actively recruiting participants, run by Hemerion Therapeutics. The registered enrollment target is 12 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT05736406, a Phase 1 study of Primary Glioblastoma, is actively recruiting participants, sponsored by Hemerion Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary objective of this clinical trial is to determine the safety and tolerability of two doses of light in intraoperative PDT added to standard of care; temozolomide-based chemotherapy in male and female patients aged 18 to 75 with newly diagnosed glioblastoma. This treatment will be carried out in addition to the maximal surgical resection. Data collected during this trial will be used to design the upcoming pivotal study . The study will utilize an independent Data and Safety Monitoring Board (iDSMB) that will review safety data to allow dose escalation.
Conditions Studied
Interventions
- COMBINATION_PRODUCT 5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 200 J/cm^2
- COMBINATION_PRODUCT 5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 400 J/cm^2
Study Locations (2)
Pennsylvania
- UPMC Hillman Cancer center - Pittsburgh
Other
- CHU De Lille, Hôpital Roger Salengro - Lille
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-02-20 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05736406
The ClinicalTrials.gov registry entry for NCT05736406 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hemerion Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which 5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 200 J/cm^2 is the first listed.
NCT05736406 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Pennsylvania, Other.
Frequently Asked Questions
What is clinical trial NCT05736406 about?
NCT05736406 is a clinical study titled "A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma". The primary objective of this clinical trial is to determine the safety and tolerability of two doses of light in intraoperative PDT added to standard of care; temozolomide-based chemotherapy in male and female patients aged 18 to 75 with newly diagnosed glioblastoma. This treatment will be carried...
What is the current status of trial NCT05736406?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2024-02-20. Estimated completion is 2026-07.
What conditions does trial NCT05736406 study?
This clinical trial studies the following conditions: Primary Glioblastoma.
What interventions are being tested in trial NCT05736406?
The interventions under investigation include: 5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 200 J/cm^2 (COMBINATION_PRODUCT), 5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 400 J/cm^2 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05736406?
This trial is sponsored by Hemerion Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05736406 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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