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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06471712




Registration number
NCT06471712
Ethics application status
Date submitted
4/06/2024
Date registered
24/06/2024

Titles & IDs
Public title
Clinical Study of 18F-LNC1007 Injection PET/CT
Scientific title
A Phase I Clinical Trial of 18F-LNC1007 Injection PET/CT in Healthy Volunteers and Light Tumor Burden Patients for Evaluating Its Pharmacokinetics, Biodistribution,Dosimetry and Safety
Secondary ID [1] 0 0
18F-LNC1007-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Cancer Patients 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 18F-LNC1007 Injection

Experimental: 18F-LNC1007 Injection - a single dose of 18F-LNC1007 Injection will be administered


Treatment: Drugs: 18F-LNC1007 Injection
Healthy volunteers will receive 1 MBq/kg and cancer patients will receive 3.7 MBq/kg. The injection will be carried out on the scan bed via an IV indwelling catheter. A 10 mL normal saline flush will be given after the completion of the injection to ensure the residue is injected.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the safety of 18F-LNC1007 injection
Timepoint [1] 0 0
Through study completion, assessed up to 2 years
Secondary outcome [1] 0 0
Evaluate the radioactivity of 18F-LNC1007 injection
Timepoint [1] 0 0
Through study completion, assessed up to 2 years
Secondary outcome [2] 0 0
Evaluate the metabolites of 18F-LNC1007 injection
Timepoint [2] 0 0
Through study completion, assessed up to 2 years
Secondary outcome [3] 0 0
Evaluate total source organ counts of 18F-LNC1007 injection
Timepoint [3] 0 0
Through study completion, assessed up to 2 years
Secondary outcome [4] 0 0
Evaluate the SUV values of 18F-LNC1007 Injection
Timepoint [4] 0 0
Through study completion, assessed up to 2 years
Secondary outcome [5] 0 0
Evaluate the image quality of 18F-LNC1007 injection
Timepoint [5] 0 0
Through study completion, assessed up to 2 years
Secondary outcome [6] 0 0
Evaluate the effective dose of 18F-LNC1007 injection
Timepoint [6] 0 0
Through study completion, assessed up to 2 years

Eligibility
Key inclusion criteria
1. Express willingness and ability to comply with all study procedures and restrictions.
2. Be healthy adult volunteers, or light tumour burden cancer patients, as defined by <5 lesions and MITV of <10ml on a PET/CT performed for clinical purposes. Eligibility includes adults of any gender.
3. Have a Body Mass Index (BMI) between 19-28 (inclusive).
4. Be capable of lying on the scanner for the duration of the PET/CT procedure, which is approximately one hour.
5. Subjects must have an adequate organ function before the administration of the 18F-LNC1007 (in the absence of blood transfusion, hematopoietic stimulating and hepatoprotective agents), as defined by:

1. White blood cell (WBC) count = 3×109/L or absolute neutrophil count (ANC) > 1.5×109/L, platelets = 100×109/L, hemoglobin (Hb) > 10.0g/dL
2. Serum albumin > 3.0 g/dL, total bilirubin < 1.5×ULN, alanine aminotransferase (ALT) < 3×ULN, aspartate aminotransferase (AST) < 3×ULN
3. Creatinine clearance = 60 mL/min (calculated using the Cockcroft-Gault formula).
6. Provide informed signed consent.
7. All females of childbearing potential (defined as premenopausal or less than 2 years post-menopausal who have not undergone surgical sterilization) must undergo a blood pregnancy test during the screening period (within 7 days before the administration of the drug). The result of the pregnancy test must be negative.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Contraindications to PET/CT scan, which include, but are not limited to, conditions like claustrophobia and pregnancy.
2. A medical history of epilepsy or seizures, excluding febrile convulsions during childhood.
3. Blood donation or experienced major blood loss (> 400 mL) within 3 months prior to the screening or during the study period.
4. For healthy volunteers: participants with a clinically significant disease or medical history as determined by the trial investigator. This includes, but is not limited to:

1. Conditions related to circulatory, respiratory, digestive, urinary, hematological, neurological, endocrine, and musculoskeletal systems.
2. History of mental disorders or any other disease with clinical significance.
3. History of major surgery or anticipated major surgery within 1 month prior to the screening or during the study period.
5. For healthy volunteers: medical comorbidities that may interfere with the absorption or metabolism of the investigational drug, limit the interpretation of the trial results, and/or are deemed clinically significant by the investigator.
6. For healthy volunteers: abnormal findings in physical examination, vital signs, laboratory tests, or 12-lead ECG during the screening period, considered clinically significant by the investigator (Baseline physical examination, laboratory tests, and 12-lead ECG can accept results from Day -7 to Day -1).
7. For healthy volunteers: use of any prescription drugs, over-the-counter drugs, or traditional herbal medicine within 14 days before administration.
8. Active and clinically significant bacterial, fungal, or viral infections, including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness (patients with treated HIV and hepatitis B or C could be included).
9. Insufficient venous access (two different venous accesses are required for the injection of the experimental drug and PK blood sampling).
10. Female participants who are pregnant (positive pregnancy test at screening) or lactating, or are of childbearing potential (premenopausal or less than 2 years post-menopausal and have not undergone surgical sterilization), who do not agree to use effective contraception (such as complete abstinence, condom use, IUD, etc.) during the trial (from the signing of the informed consent) and for one month after administration.
11. Male participants with plans for procreation or sperm donation during the trial (from the signing of the informed consent) and one month after administration or who do not wish to take effective contraceptive measures (such as complete abstinence, condom use, surgical sterilization, etc.).
12. Subjects with a history of allergies that the investigator believes could increase the trial risk.
13. Clinically significant abnormalities on electrocardiogram (ECG) at screening including QTcF > 470 ms, and subjects who cannot tolerate high volume load.
14. Subjects who have undergone radioactive drug imaging (other than 18F-FDG) or treatment within 7 days prior to screening.
15. Subjects who have participated in other clinical trials within the past 1 month before the screening visit.
16. Participation in clinical trials of radiopharmaceuticals within 1 year prior to screening.
17. History of long exposure to high-dose radiation.
18. Subjects with a history of drug or alcohol abuse within the past year or a long-term history of drug use.
19. For light tumor burden patients: concurrent anti-cancer treatment;
20. For light tumor burden patients: previous major surgeries or anticipated major surgery within 1 month prior to the screening or during the study period.
21. Other conditions that the investigator believes render the participant not suitable for participating in the trial.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Precision Molecular Imaging & Theranostics (trading as Melbourne Theranostic Innovation Centre) - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Yantai LNC Biotechnology Singapore PTE. LTD.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06471712