Clinical Study of 68Ga-LNC1007 Injection PET/CT
NCT Number: NCT06463782
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers|Cancer Patients
Interventions: DRUG: 68Ga-LNC1007 Injection
Sponsor: Yantai LNC Biotechnology Singapore PTE. LTD.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09
Completion Date: 2026-09
Locations: Clinical Imaging Research Centre (CIRC) ；National University of Singapore., Singapore, Singapore

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.

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.

Primary Outcome Measures: 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., Through study completion, assessed up to 2 years
Secondary Outcome Measures: 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., Through study completion, assessed up to 2 years|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., Through study completion, assessed up to 2 years|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., Through study completion, assessed up to 2 years|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., Through study completion, assessed up to 2 years