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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hemerion Therapeutics

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

29 Sep 2025 → ongoing

Decision date (initial)

2025-06-16

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Hemerion Therapeutics

External identifiers

EU CT number

2025-520563-41-00

ClinicalTrials.gov

NCT05736406

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

Safety and tolerability of intraoperative PDT regimen in patients with GBM by determining the MTD and the recommended dose light for the pivotal trial.

Secondary objectives 3

1. Treatment response by MRI imaging after intraoperative PDT
2. Global safety
3. Usability of the Heliance® Solution in the operating room

Conditions and MedDRA coding

High-grade glioma Glioblastoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Males or females must be between 18, or legal age of consent, and 75 years of age (both included) at the time of signing informed consent.
2. Signed informed consent which includes compliance with requirements and restrictions listed in the informed consent.
3. Newly diagnosed GBM, presumed on the basis of clinical and MRI criteria (intra-axial brain tumor with peripheral rim contrast enhancement).
4. Karnofsky Performance Score ≥70
5. Eligible for surgery
6. Amenable to maximal tumor resection based on MRI
7. Planned to receive SOC (i.e., Stupp Protocol) treatment after surgery
8. Ability to take oral medications
9. Tumor eligible to PDT procedure as validated by both investigator and sponsor based on pre-operative MRI data

Exclusion criteria 19

1. a. Patient with bifocal or multifocal disease, assessed on MR1I T1Gd enhanced. b. Patient with tumor of deep location such as tumor involving the corpus callosum, the basal ganglia, the brain stem, or tumor involving the midline as assessed on MRI. c. Patient with prior brain surgery other than stereotactic biopsy
2. Patient with Lynch syndrome
3. Patient with Li-Fraumeni syndrome
4. Debilitating cardiopulmonary disease, unstable Type 1 or Type 2 diabetes (treated or not)
5. History or current condition of another malignancy (excluding basal cell carcinoma, or carcinoma in-situ) unless treated and off all active therapy for more than 5 years.
6. Clinically significant abnormal ECG results, including a corrected QT interval QTc > 480 ms.
7. Creatinine clearance < 60 mL/min
8. Severe hepatic impairment (bilirubin > 1.5 x the upper limit of normal [ULN] or alkaline phosphatase or transaminases (AST, ALT) > 2.5 x ULN)
9. Known allergic reactions to silicone.
10. Known allergic reactions or hypersensitivity to egg, soya, or peanut proteins.
11. Febrile illness
12. Contraindication to 5-ALA HCl administration, including: a) Porphyria b) Taking photosensitizing drugs 24 hours before and 14 days after the administration of Pentalafen® including but not limited to: St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, tetracyclines, and topical preparations containing ALA c) Inability to suspend a long-term hepatotoxic treatment (such as, but not limited to diclofenac, fenofibrate, carbamazepine for 24 hours after 5-ALA HCl intake.
13. Contraindication to MRI examination (e.g., MRI-incompatible pacemaker)
14. Treatment with another investigational drug or intervention within 30 days prior to or during the entire study
15. Predictable non-compliance with the rules for preventing the transient risk of skin photosensitization.
16. Clinical follow up not possible for psychological, family, social, or geographic reasons.
17. Legal incapacity
18. Pregnancy or lactation
19. Women of childbearing potential (WOCBP) and males with WOCBP partners not willing to use an effective contraceptive method from inclusion until end of study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 3

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hemerion Therapeutics

Sponsor organisation

Hemerion Therapeutics

Address

37 Rue Denis Papin

City

Villeneuve D Ascq

Postcode

59650

Country

France

Scientific contact point

Organisation

Hemerion Therapeutics

Contact name

Maximilien Vermandel

Public contact point

Organisation

Hemerion Therapeutics

Contact name

Antoine Mequignon

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications