FG001 in subjects with Meningiomas or presumed Low-Grade Gliomas scheduled for neurosurgery.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Copenhagen University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-01-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2024-520426-11-00

EudraCT number

2023-000163-31

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

To evaluate FG001 for the detection of meningioma, or presumed low-grade glioma (pLGG).

Secondary objectives 2

1. To evaluate the pharmacokinetics profile of single dose FG001
2. To evaluate safety and tolerability

Conditions and MedDRA coding

Glioma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Subjects diagnosed with primary brain tumor on MRI suggestive of primary meningioma or presumed low-grade glioma (pLGG)
2. Scheduled for neurosurgery with the objective to remove cancer tissue
3. Subjects aged 18 years or older
4. Capable of understanding and giving written informed consent
5. Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 30 days after the end-of-trial visit. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilised or infertile, females must have undergone surgical sterilisation (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea; may be confirmed with follicle-stimulating hormone [FSH] test if there is doubt)
6. Male subjects must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit
7. Subject must not previously have received the trial drug (FG001)
8. Subjects must have normal organ and bone marrow function and be appropriate surgical candidates per site standard of care (SOC)

Exclusion criteria 5

1. Any known allergy or hypersensitivity to indocyanine green (ICG)
2. Female subjects who are pregnant or breast-feeding (pregnancy test positive prior to inclusion (or if breast- feeding willing to pause breast feeding during trial and for 30 days
3. Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the Investigator
4. Pre-existing hepatic and/or renal insufficiency (INR > 1,7, Estimated GFR (eGFR) <45 ml/min/1,73m2)
5. Unwilling or unable to follow the protocol requirements

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Sensitivity detection of tumor tissue in meningioma with its dural attachment, and pLGG using histology as a reference.

Secondary endpoints 2

1. Efficacy (Demonstrate exposure of FG001)
2. Safety and tolerability (Adverse Events, laboratory parameters, 12 - lead ECG parameters, vital signs)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Copenhagen University Hospital

Sponsor organisation

Copenhagen University Hospital

Address

Blegdamsvej 9

City

Copenhagen Oe

Postcode

2100

Country

Denmark

Scientific contact point

Organisation

Copenhagen University Hospital

Contact name

Jane Skjoeth-Rasmussen

Public contact point

Organisation

Copenhagen University Hospital

Contact name

Jane Skjoeth-Rasmussen

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

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

Documents 6 files

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

Application history

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