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Healthy VolunteersPhase 1NCT06463782

Clinical Study of 68Ga-LNC1007 Injection PET/CT

A Phase 1 study testing 68Ga-LNC1007 Injection in people with Healthy Volunteers and Cancer Patients, run by Yantai LNC Biotechnology Singapore PTE. LTD. at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a single-arm, single-center trial aimed at evaluating the safety, pharmacokinetics, biodistribution and dosimetry of 68Ga-LNC1007 Injection in adult healthy volunteers and solid tumor patients. All participants must provide a signed informed consent form before enrolling in the trial. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers, Cancer Patients
What is being tested?
68Ga-LNC1007 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteSingapore
Study dates
2 Jan 2025to 27 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Understand the study procedures and agree to participate by providing a signed informed consent form.
  • Be willing and able to comply with all study procedures and restrictions.
  • Be ≥ 21 years of age (a balanced gender ratio is preferred.).
  • Have a body mass index (BMI) between 19-26 (inclusive).
  • Be capable of laying on the scanner for a consecutive hour.
  • All females of childbearing potential (premenopausal or less than 2 years post-menopausal and have not undergone surgical sterilization) must undergo a blood pregnancy test during the screening period. The results of the pregnancy test must be negative, and these participants must be using effective contraception, such as complete abstinence, condom use, IUD, etc.
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  • Additional inclusion criteria for patients:
  • Patients must have histological, pathological and/or cytological confirmation of solid malignant tumor.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • According to the investigator's judgment, the expected survival time must be more than 6 months.
  • Patients must have an adequate organ function before the administration of the 68Ga-LNC1007 (in the absence of blood transfusion, hematopoietic stimulating and hepatoprotective agents), as defined by:
  • 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
  • Serum albumin > 3.0 g/dL, total bilirubin < 1.5×ULN, alanine aminotransferase (ALT) < 3×ULN, aspartate aminotransferase (AST) < 3×ULN
  • Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).

Who cannot join

  • Contraindications to PET/CT scan, which include, but are not limited to, conditions like claustrophobia.
  • A medical history of epilepsy or seizures, excluding febrile convulsions during childhood.
  • Blood donation or otherwise major blood loss (> 400 mL) within 3 months prior to the screening or during the study period.
  • 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).
  • Insufficient venous access (two different venous accesses are required for the injection of the experimental drug and PK blood sampling).
  • Females who are pregnant (positive pregnancy test at screening period), lactating, or have fertility potential (premenopausal or less than 2 years post-menopausal and have not undergone surgical sterilization) and refusal to use effective contraception (such as complete abstinence, condom use, IUD, etc.) during the trial (from the signing of the informed consent form) and three months after administration.
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  • Males with plans for procreation or sperm donation during the trial (from the signing of the informed consent form) and three months after administration. Males who do not wish to take effective contraceptive measures should be excluded as well (such as complete abstinence, condom use, surgical sterilization, etc.).
  • History of alcohol allergy, polyethylene glycol (PEG) allergy or other allergies that the investigator considers could increase the trial risk.
  • Radioactive drug imaging or treatment within 7 days prior to screening.
  • Participation in other clinical trials within the past 1 months before screening visit.
  • Participation in clinical trials of radiopharmaceuticals within 1 year prior to screening.
  • History of drug or alcohol abuse within the past year, or a long-term history of illegal drug use.
  • History of long exposure to high-dose radiation.
  • Other conditions that the investigator believes make the subject unsuited for participating in the trial. For example, active infections requiring intravenous antibiotic treatment 14 days prior to administration.
  • Additional exclusion criteria for healthy volunteers:
  • Clinically significant disease or medical history as determined by the trial investigator. This includes, but is not limited to:
  • Conditions related to circulatory, respiratory, digestive, urinary, hematological, neurological, endocrine, and musculoskeletal systems.
  • History of mental disorders or any other disease with clinical significance.
  • Previous major surgeries or anticipated major surgery within 1 month prior to the screening or during the study period.
  • Currently having medical comorbidities that are considered to be clinically significant by investigators, such as comorbidities that may interfere with the absorption or metabolism of the investigational drug or limit the interpretation of the trial results.
  • Having taken any prescription drugs, over-the-counter drugs, health products, or traditional herbal medicine within 14 days before administration.
  • Abnormal findings considered clinically significant by investigators during the screening period, such as physical examination, vital signs, laboratory tests or 12-lead ECG (baseline physical examination, laboratory tests, and 12-lead ECG results are acceptable from Day -7 to Day -1).
  • Additional exclusion criteria for patients:
  • Concurrent anti-cancer treatment.
  • A history of mental disorders or any other disease with clinical significance.
  • Previous major surgeries or anticipated major surgery within 1 month prior to the screening or during the study period.
  • Concurrent other disease like metabolic abnormality, abnormal physical examination, or abnormal laboratory test at the time of screening, which will make the patient reasonably suspected to be unsuitable for receiving the study drug, or will affect the interpretation of the study results, or will put the subject at high risk such as idiopathic pulmonary fibrosis or lung disease, urinary incontinence, etc., according to the investigator's judgment.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Clinical Imaging Research Centre (CIRC) ；National University of Singapore.

    Singapore

Other trials in Singapore

About this study

Official title: Phase I Clinical Trial of the Safety, Pharmacokinetics, Biodistribution and Dosimetry of 68Ga-LNC1007 Injection in Adult Healthy Volunteers and Solid Tumor Patients

This study is a single-arm, single-center trial aimed at evaluating the safety, pharmacokinetics, biodistribution and dosimetry of 68Ga-LNC1007 Injection in adult healthy volunteers and solid tumor patients.

All participants must provide a signed informed consent form before enrolling in the trial.

A total of 8 adult healthy volunteers and solid tumor patients will be involved in the trial. There should be no less than 3 and no more than 5 participants in either group. If any participant drops out during the trial, or an effective scan image becomes unavailable, additional volunteers will be recruited to ensure the sample size. The participant will receive a single intravenous injection with 68Ga-LNC1007 Injection.Each subject will participate in the study for approximately 3 weeks, including 2 weeks of screening, 1 week of scanning and safety follow-up.

Being tested
68Ga-LNC1007 Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-LNC1007 InjectionDrug

    The participant will receive a single intravenous injection with 0.05 mCi/kg (according to the participants' body weight) 68Ga-LNC1007 Injection on the scan bed. The final dose of the drug is allowed to fluctuate within the 20% range, but not below 3 mCi. A 10 mL normal saline flush will be given after the completion of the injection to ensure the residue is injected.

Study groups in NCT06463782
Study groupRoleWhat they receive
68Ga-LNC1007 InjectionExperimentala single dose of 68Ga-LNC1007 Injection will be administered
Receives: Drug: 68Ga-LNC1007 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the safety of 68Ga-LNC1007 Injection.

    The safety assessments of this phase I trial are based on systemic safety evaluation. The frequency and severity of Treatment emergent adverse events (TEAE) will be classified according to Common Toxicity Criteria for Adverse Events 5.0. The seriousness and relationship of study treatment will be assessed.

    Measured: Through study completion, assessed up to 2 years

Secondary outcomes (4)

  1. Evaluate the radioactivity of 68Ga-LNC1007 Injection.

    Patient blood samples at 5 min, 15 min , 30 min , 60 min , 120 min , 180 min , 240 min，24 h after the administration of 68Ga-LNC1007.

    Patient urine samples at 0-1.5 h, 1.5-3 h and 3-4 h after the administration of 68Ga-LNC1007.

    All samples will be drawn for radioactivity by a gamma counter.

    Measured: Through study completion, assessed up to 2 years

  2. Evaluate the metabolites of 68Ga-LNC1007 Injection.

    Patient blood samples at 5 min , 60 min , 120 min , 180 min , 240 min，24 h after the administration of 68Ga-LNC1007.

    Patient urine samples at 0-1.5 h, 1.5-3 h and 3-4 h after the administration of 68Ga-LNC1007.

    The major metabolites will be conducted by radioHPLC.

    Measured: Through study completion, assessed up to 2 years

  3. Evaluate the radioactive counts of each target organ of 68Ga-LNC1007 Injection.

    Whole-body images will be acquired by using standard methods. The whole-body PET scan images will be evaluated and the regions of interest (ROI) such as heart, lung, liver, kidney, spleen, and brain, will be delineated on the whole-body image of each phase to obtain the radioactive counts of each target organ in each phase.

    Measured: Through study completion, assessed up to 2 years

  4. Evaluate the SUV values of 68Ga-LNC1007 Injection.

    The SUV values (SUVmax, SUVmean) of each organ will be summarized to reflect the biodistribution of 68Ga-LNC 1007 Injection in the human body.

    Measured: Through study completion, assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study start2 Jan 2025
  3. Primary completion27 May 2025
  4. Study completion27 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06463782
Sponsor's protocol ID
68Ga-LNC1007-001
Status last verified
Sep 2025
First submitted
4 Jun 2024
Last updated
3 Sep 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 68Ga-LNC1007 Injection in people with Healthy Volunteers and Cancer Patients, run by Yantai LNC Biotechnology Singapore PTE. LTD. at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety of 68Ga-LNC1007 Injection. (time frame: Through study completion, assessed up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06463782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.

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