Evaluating 68Ga-LNC1007 Injection in healthy volunteers and cancer patients

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 testing a new injection called 68Ga-LNC1007 in healthy volunteers and cancer patients to see how safe it is and how it moves through the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Yantai LNC Biotechnology Singapore PTE. LTD. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Singapore)
• Trial ID: NCT06463782 on ClinicalTrials.gov

What this trial studies

This clinical trial is a single-arm, single-center evaluation of the safety, pharmacokinetics, biodistribution, and dosimetry of 68Ga-LNC1007 Injection. It involves adult healthy volunteers and patients with solid tumors, with a total of 8 participants expected. Each participant will receive a single intravenous injection and will be monitored over approximately 3 weeks, including screening, scanning, and safety follow-up. The study aims to gather important data on the injection's effects and distribution in the body.

Who should consider this trial

Good fit: Ideal candidates include adults aged 21 and older with a confirmed diagnosis of solid malignant tumors or healthy volunteers meeting specific health criteria.

Not a fit: Patients with a BMI outside the range of 19-26 or those unable to comply with study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of 68Ga-LNC1007 Injection's safety and effectiveness in imaging solid tumors.

How similar studies have performed: While this approach is novel, similar studies evaluating imaging agents have shown promise in enhancing cancer diagnostics.

Eligibility criteria

Inclusion Criteria:

* 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.

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:

  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).

Exclusion Criteria:

* 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.
* 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:

  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. 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.

Where this trial is running

Singapore

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

Conditions Healthy Volunteers; Cancer Patients