FG001 for Glioma|Meningioma

Inclusion criteria

• {"criterion_text":"- Subjects diagnosed with primary brain tumor on MRI suggestive of primary meningioma or presumed low-grade glioma (pLGG)\n- Scheduled for neurosurgery with the objective to remove cancer tissue\n- Subjects aged 18 years or older\n- Capable of understanding and giving written informed consent\n- 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)\n- Male subjects must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit\n- Subject must not previously have received the trial drug (FG001)\n- Subjects must have normal organ and bone marrow function and be appropriate surgical candidates per site standard of care (SOC)"}

Exclusion criteria

• {"criterion_text":"- Any known allergy or hypersensitivity to indocyanine green (ICG)\n- 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\n- Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the Investigator\n- Pre-existing hepatic and/or renal insufficiency (INR > 1,7, Estimated GFR (eGFR) <45 ml/min/1,73m2)\n- Unwilling or unable to follow the protocol requirements"}

Primary endpoints

• {"endpoint_text":"- Sensitivity detection of tumor tissue in meningioma with its dural attachment, and pLGG using histology as a reference.","definition_or_measurement_approach":"Sensitivity of FG001 to detect tumor tissue in meningioma (including dural attachment) and presumed low-grade glioma (pLGG), using histology (post-operative histopathology) as the reference standard."}

Secondary endpoints

• {"endpoint_text":"- Efficacy (Demonstrate exposure of FG001)","definition_or_measurement_approach":"Assessment of exposure consistent with pharmacokinetic evaluation of single-dose FG001."}
• {"endpoint_text":"- Safety and tolerability (Adverse Events, laboratory parameters, 12 - lead ECG parameters, vital signs)","definition_or_measurement_approach":"Collection and review of adverse events, laboratory parameters, 12-lead ECGs and vital signs to evaluate safety and tolerability."}

Denmark

Earliest CTIS Part Ii Submission Date

23-01-2025

Latest Decision Or Authorization Date

29-01-2025

Processing Time Days

6

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Copenhagen University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP-unit at Copenhagen University Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Health care"}