A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma

Phase 1

Recruiting

• Conditions: Primary Glioblastoma
• 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

• Registration Number: NCT05736406
• Lead Sponsor: Hemerion Therapeutics

Brief 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.

Detailed Description

This study is a non randomized, open label, single center , phase 1/2 trial with a sequential enrollment in a 3+3 dose escalation design to establish the maximal tolerated dose of light (MTD).

The dose of light will be escalated in successive cohorts of patients until at least 1 patient experiences a dose-limiting toxicity (DLT).

A DLT is defined as any grade ≥ 3 Adverse Event (AE), or any relevant grade 2 AE of Central Nervous System or any Serious Adverse Events (SAEs) possibly, probably or definitively related to the intraoperative PDT (i.e., 5-aminolevulinic acid hydrochloride (5-ALA HCl) administration + brain cavity illumination), for which the onset date is within 28 days after the procedure, and where conservative therapy fails and surgical is required, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

After dose escalation patient will be followed in the standard of care until visit at 6 months to evaluate the progression free survival.

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-21
• Study Start: 2024-02-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-12
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
200 J/cm^2	5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 200 J/cm^2	Patient will undergo intraoperative Photodynamic therapy at 200 J/cm\^2
400 J/cm^2	5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 400 J/cm^2	Patient will undergo intraoperative Photodynamic therapy at 400 J/cm\^2

Primary Outcome Measures

Name	Time	Method
Maximal Tolerated Dose (MDT) of light for Photodynamic Therapy	4 weeks after intervention	Evaluation of Dose Limiting Toxicities (DLT) to define MDT

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events and Serious Adverse Events (Safety and Tolerability)	6 months	Global clinical safety data of 5-ALA HCl Intraoperative PDT
Treatment response / Progression-free survival (PFS)	Up to 6 months after intervention	MRI imaging and RANO criteria

Trial Locations

Locations (1)

UPMC Hillman Cancer center; 🇺🇸 Pittsburgh, Pennsylvania, United States