FG001 in patients with non-small cell lung cancer

An open-label, non-randomized, single dose, exploratory Phase II trial of FG001 (an imaging agent) for localization of biopsy-proven primary non-small cell lung cancer (NSCLC)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004389-37-DK

Enrollment

Registered

2021-12-22

Start date

2022-03-24

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: FG001 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: Not available Current Sponsor code: FG001 Other descriptive name: FG001 sodium Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients are eligible to enter into this trial only if they meet all of the following criteria: 1. Biopsy-verified NSCLC (adenocarcinoma or squamous-cell carcinoma) and scheduled for surgery (VATS). Note that biopsy-verified NSCLC refers to the biopsy upon which the patient was diagnosed with NSCLC 2. Peripheral location of the tumor (based on CT/MRI/PET scan no later than 8 weeks old from screening date or a scan must be taken at baseline visit) 3. Tumor size = 1.5 cm 4. No suspicion of metastatic disease 5. Patients aged 18 years or older 6. Capable of understanding and giving written informed consent 7. Patient must not previously have received the trial drug (FG001) 8. Male patients must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit and avoid sperm donation during this period 9. 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

Exclusion criteria: Patients are eligible to enter into this trial only if they do NOT meet any of the following criteria: 1. Any known allergy or hypersensitivity to indocyanine green (ICG) or any other component of the drug product 2. Female patients who are pregnant or breast-feeding (pregnancy test positive prior to inclusion) 3. Overall performance status or co-morbidity deeming the patient 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

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate FG001 for the detection of NSCLC ;Secondary Objective: - To evaluate the pharmacokinetics profile of single dose FG001 - To evaluate safety and tolerability ;Primary end point(s): - Sensitivity for detection of NSCLC ;Timepoint(s) of evaluation of this end point: The efficacy of FG001 (as a tumor imaging agent) is examined by the sensitivity, which is verified via the intensity of fluorescence from the biopsies. TBR will be calculated as the fluorescence of the tumor relative to background tissue, as measured by near-infrared (NIR) imaging. This is imaged in situ during resection.	—

Measure

Time frame

Main Objective: - To evaluate FG001 for the detection of NSCLC ;Secondary Objective: - To evaluate the pharmacokinetics profile of single dose FG001 - To evaluate safety and tolerability ;Primary end point(s): - Sensitivity for detection of NSCLC ;Timepoint(s) of evaluation of this end point: The efficacy of FG001 (as a tumor imaging agent) is examined by the sensitivity, which is verified via the intensity of fluorescence from the biopsies. TBR will be calculated as the fluorescence of the tumor relative to background tissue, as measured by near-infrared (NIR) imaging. This is imaged in situ during resection.

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Secondary

Measure	Time frame
Secondary end point(s): a. Efficacy For cohort 1: PK profile determined by non-compartmental analysis: - Peak plasma concentration (Cmax) - Time of peak plasme concentration (tmax) - Area under the plasma concentration-time curve from time-zero extrapolated to infinity (AUC0-inf) - Area under the plasma concentration-time curve from time-zero to last quantifiable concentration (AUC0-t) - Terminal half-life (t½) For cohort 2 and onwards: - Demonstrate exposure of FG001 after 1 hour and prior to surgery b. Safety and tolerability - Adverse Events - Laboratory parameters - 12 - lead ECG parameters - Vital Signs ;Timepoint(s) of evaluation of this end point: For cohort 1: Samples will be used to evaluate the PKs of FG001 and will be taken at the following timepoints from the administration of FG001: +1 Hour (± 15 mins), +13 hours (±2 hours), +24 hours (± 4 hours), +36 hours (± 4 hours), and +44 hours (± 6 hours). Safety and tolerability will be evaluated throughout the trial. For cohort 2 and onwards: Samples will be used to evaluate the PKs of FG001 and will be drawn at the following timepoints from administration of FG001: Day 1 (+1 hour (± 15 mins), and Day 3 in the morning prior to surgery (between 7 and 9 am).	—

Measure

Time frame

Secondary end point(s): a. Efficacy For cohort 1: PK profile determined by non-compartmental analysis: - Peak plasma concentration (Cmax) - Time of peak plasme concentration (tmax) - Area under the plasma concentration-time curve from time-zero extrapolated to infinity (AUC0-inf) - Area under the plasma concentration-time curve from time-zero to last quantifiable concentration (AUC0-t) - Terminal half-life (t½) For cohort 2 and onwards: - Demonstrate exposure of FG001 after 1 hour and prior to surgery b. Safety and tolerability - Adverse Events - Laboratory parameters - 12 - lead ECG parameters - Vital Signs ;Timepoint(s) of evaluation of this end point: For cohort 1: Samples will be used to evaluate the PKs of FG001 and will be taken at the following timepoints from the administration of FG001: +1 Hour (± 15 mins), +13 hours (±2 hours), +24 hours (± 4 hours), +36 hours (± 4 hours), and +44 hours (± 6 hours). Safety and tolerability will be evaluated throughout the trial. For cohort 2 and onwards: Samples will be used to evaluate the PKs of FG001 and will be drawn at the following timepoints from administration of FG001: Day 1 (+1 hour (± 15 mins), and Day 3 in the morning prior to surgery (between 7 and 9 am).

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Countries

Denmark

Contacts

Public ContactRegulatory Affairs

Ozack ApS

ack@ozack.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026