Aminolevulinic acid hydrochloride for Glioblastoma|High-grade glioma

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Signed informed consent which includes compliance with requirements and restrictions listed in the informed consent."}
• {"criterion_text":"- Newly diagnosed GBM, presumed on the basis of clinical and MRI criteria (intra-axial brain tumor with peripheral rim contrast enhancement)."}
• {"criterion_text":"- Karnofsky Performance Score ≥70"}
• {"criterion_text":"- Eligible for surgery"}
• {"criterion_text":"- Amenable to maximal tumor resection based on MRI"}
• {"criterion_text":"- Planned to receive SOC (i.e., Stupp Protocol) treatment after surgery"}
• {"criterion_text":"- Ability to take oral medications"}
• {"criterion_text":"- Tumor eligible to PDT procedure as validated by both investigator and sponsor based on pre-operative MRI data"}

Exclusion criteria

• {"criterion_text":"- a.\tPatient with bifocal or multifocal disease, assessed on MR1I T1Gd enhanced. b.\tPatient 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.\tPatient with prior brain surgery other than stereotactic biopsy"}
• {"criterion_text":"- Known allergic reactions or hypersensitivity to egg, soya, or peanut proteins."}
• {"criterion_text":"- Febrile illness"}
• {"criterion_text":"- Contraindication to 5-ALA HCl administration, including: a)\tPorphyria b)\tTaking 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)\tInability to suspend a long-term hepatotoxic treatment (such as, but not limited to diclofenac, fenofibrate, carbamazepine for 24 hours after 5-ALA HCl intake."}
• {"criterion_text":"- Contraindication to MRI examination (e.g., MRI-incompatible pacemaker)"}
• {"criterion_text":"- Treatment with another investigational drug or intervention within 30 days prior to or during the entire study"}
• {"criterion_text":"- Predictable non-compliance with the rules for preventing the transient risk of skin photosensitization."}
• {"criterion_text":"- Clinical follow up not possible for psychological, family, social, or geographic reasons."}
• {"criterion_text":"- Legal incapacity"}
• {"criterion_text":"- Pregnancy or lactation"}
• {"criterion_text":"- Women of childbearing potential (WOCBP) and males with WOCBP partners not willing to use an effective contraceptive method from inclusion until end of study"}
• {"criterion_text":"- Patient with Lynch syndrome"}
• {"criterion_text":"- Patient with Li-Fraumeni syndrome"}
• {"criterion_text":"- Debilitating cardiopulmonary disease, unstable Type 1 or Type 2 diabetes (treated or not)"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Clinically significant abnormal ECG results, including a corrected QT interval QTc > 480 ms."}
• {"criterion_text":"- Creatinine clearance < 60 mL/min"}
• {"criterion_text":"- Severe hepatic impairment (bilirubin > 1.5 x the upper limit of normal [ULN] or alkaline phosphatase or transaminases (AST, ALT) > 2.5 x ULN)"}
• {"criterion_text":"- Known allergic reactions to silicone."}

Primary endpoints

• {"endpoint_text":"- MTD, which will be assessed on the basis of number of patients with DLT.","definition_or_measurement_approach":"MTD assessed on the basis of number of patients with dose-limiting toxicity (DLT)."}

Secondary endpoints

• {"endpoint_text":"- PFS6, defined as the interval (in days or months) from intraoperative PDT to the date of first detection of progressive disease.","definition_or_measurement_approach":"PFS6 measured as interval from intraoperative PDT to date of first detection of progressive disease (in days or months)."}
• {"endpoint_text":"- Number of AEs and SAEs","definition_or_measurement_approach":"Count and reporting of adverse events (AEs) and serious adverse events (SAEs) per standard safety reporting."}
• {"endpoint_text":"- Score of device usability calculated from usefulness, ease of use, ease of learning and satisfaction/intention of use measures.","definition_or_measurement_approach":"Usability score calculated from measures of usefulness, ease of use, ease of learning and satisfaction/intention of use."}

France

Earliest CTIS Part Ii Submission Date

28-04-2025

Latest Decision Or Authorization Date

16-06-2025

Processing Time Days

49

Number Of Sites

1

Number Of Participants

6

Primary sponsor

Full Name

Hemerion Therapeutics

Organisation Type

Pharmaceutical company

Country Of Registered Address

France