Clinical Study of 68Ga-LNC1007 Injection PET/CT

Launched by YANTAI LNC BIOTECHNOLOGY SINGAPORE PTE. LTD. · Jun 13, 2024

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ClinConnect Summary

The clinical trial titled "Clinical Study of 68Ga-LNC1007 Injection PET/CT" is designed to evaluate a new imaging agent called 68Ga-LNC1007 Injection. This agent will be tested for safety and how it moves through the body in both healthy adults and cancer patients. The study will include 8 participants, with a mix of healthy volunteers and patients with solid tumors. To be eligible, participants must be at least 21 years old, understand the study well, and provide signed consent. They should also have a specific body weight range and be able to lie still for about an hour during the scan. For cancer patients, additional criteria include having a confirmed diagnosis and an expected survival time of over 6 months.

Participants can expect to be involved in the trial for about three weeks, which includes two weeks for screening and one week for the actual scanning and follow-up. During the trial, they will receive a single injection of the study drug. It's important to note that the study is not yet recruiting participants, and there are strict guidelines about who can join to ensure everyone's safety and the quality of the research. If a participant drops out, more volunteers may be recruited to keep the study on track.

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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.