Evaluation of the feasibility of PD L 506 for stereotactic interstitial photodynamic therapy (iPDT) in adult patients with newly diagnosed supratentorial IDH wild-type glioblastoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Photonamic GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

3 Sep 2021 → 9 Apr 2026

Decision date (initial)

2024-07-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2023-510024-79-00

EudraCT number

2016-004775-51

ClinicalTrials.gov

NCT03897491

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To determine safety and tolerability of iPDT with PD L 506 in adult patients with newly diagnosed supratentorial IDH wild-type glioblastoma.

Conditions and MedDRA coding

Glioblastoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Biopsy proven, newly diagnosed, supratentorial, unifocal, lobar located IDH wild-type glioblastoma according to the criteria of the 2016 WHO classification.  Not safely and/or not completely resectable, lobar located, unifocal, supratentorial IDH wildtype glioblastomas with a largest diameter ≤ 40 mm (largest diameter of the contrast enhanced tumor, as defined by enhanced T1 MRI sequences) are eligible in case of corresponding tumor board re-estimations.  Potentially completely resectable, lobar located, unifocal, supratentorial, IDH wild-type glioblastoma with a largest diameter ≤ 40 mm are eligible in case of both patient’s informed preference in favour of iPDT and corresponding tumor board recommendations.  Age 18 - 70 years  Karnofsky Performance status (KPS) of ≥ 70 %  Minimal life expectancy of 3 months.  Patients eligible for radiotherapy plus concomitant and adjuvant chemotherapy with temozolomide: - Adequate haematological function (Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count > 100 x 109/L, Haemoglobin > 10 g/dL (may be transfused to maintain or exceed this level)).  International normalized ratio (INR) or PT (secs) and activated partial thromboplastin time (aPTT) ≤ 1,5 times of the upper limit of normal in the laboratory where it was measured.  Negative pregnancy test in fertile womenFor female and male patients of reproductive potential: Willingness to apply highly effective contraception (Pearl index <1) during the entire study. Such methods include3: - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal - progestogen-only hormonal contraception associated with inhibition of ovulation : o oral o injectable o implantable - intrauterine device (IUD) - intrauterine hormone-releasing system (IUS) - bilateral tubal occlusion - vasectomised partner - sexual abstinence  Written informed consent has been signed and dated prior to or at the beginning of Visit -1

Exclusion criteria 1

1.  Glioblastomas involving the basal ganglia, the corpus callosum, the primary motor cortex, the ventricular system, multifocal tumors, and those involving the brain stem and/or the cerebellum.  Glioblastomas exceeding the 40 mm threshold in their largest diameter  Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)  Hypersensitivity against porphyrins  Known diagnosis of porphyria  Acute or chronic hepatic diseases (levels of ASAT, ALAT and/or GT more than 2.5 times the upper limit of normal in the laboratory where it was measured)  Manifest renal diseases with renal dysfunction (serum creatinine level > 1.5 times of the upper limit of normal in the laboratory where it was measured)  Severe, active co-morbidity:  Unstable angina and/or congestive heart failure within the last 6 months  Transmural myocardial infarction within the last 6 months  History of stroke, cerebral vascular accident, or transient ischemic attack within 6 months  Serious and inadequately controlled cardiac arrhythmia  Significant vascular disease (e.g. aortic aneurysm)  Evidence of bleeding diathesis or coagulopathy  Acute bacterial or fungal infections  Acute exacerbation of chronic obstructive pulmonary disease  Hepatic insufficiency resulting in clinical jaundice and/or coagulopathy Acquired immune deficiency syndrome; note, however, that HIV testing is not required for study entry.  Inability to undergo MRI (e.g., presence of a pacemaker)  Known intolerance to study medication  Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent  Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment or within 5 plasma half-life of the preceding study drug, whatever is longer.  Pregnancy or breastfeeding  In case of both complete absence of intra-operative fluorescence between any of the inserted light diffusers and absence of significant surgery-associated bleedings (i.e. light transmission is detectable between at least two of the inserted light diffusers), the tumor will be classified as ‘fluorescence-negative tumor’. iPDT will however be performed. Regarding efficacy evaluation, patients with fluorescence-negative tumors will be excluded from PP-, but included in the ITT-evaluation, and will be evaluated regarding safety.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The incidence of treatment-emergent Adverse Events (TEAEs) of CTC grades 3, 4 and 5 within two weeks following iPDT.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Photonamic GmbH & Co. KG

Sponsor organisation

Photonamic GmbH & Co. KG

Address

Eggerstedter Weg 12

City

Pinneberg

Postcode

25421

Country

Germany

Scientific contact point

Organisation

Photonamic GmbH & Co. KG

Contact name

Clinical project management department

Public contact point

Organisation

Photonamic GmbH & Co. KG

Contact name

Clinical project management department

Locations

1 EU/EEA country · 3 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

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