An interventional, multicenter, and international phase 1/2, light-dose-escalation study to investigate the safety and feasibility of intraoperative photodynamic therapy (PDT) with Pentalafen® drug and Heliance® Solution device in male and female patients 18 to 75 years of age with grade IV glioblastoma.

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520563-41-00

Acronym

HTX-GBM-01

Enrollment

Registered

2025-06-16

Start date

2025-09-29

Completion date

Unknown

Last updated

2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-grade glioma Glioblastoma

Brief summary

MTD, which will be assessed on the basis of number of patients with DLT.

Detailed description

PFS6, defined as the interval (in days or months) from intraoperative PDT to the date of first detection of progressive disease., Number of AEs and SAEs, Score of device usability calculated from usefulness, ease of use, ease of learning and satisfaction/intention of use measures.

Interventions

DRUGPentalafen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
MTD, which will be assessed on the basis of number of patients with DLT.	—

Secondary

Measure	Time frame
PFS6, defined as the interval (in days or months) from intraoperative PDT to the date of first detection of progressive disease., Number of AEs and SAEs, Score of device usability calculated from usefulness, ease of use, ease of learning and satisfaction/intention of use measures.	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026