Yantai Lannacheng Biotechnology Co., Ltd.

This proposal is a phase I, open-label study of a 3-Dose Regimen of Escalating Doses of 177Lu-LNC1003 Injection in patients with PSMA-positive mCRPC.
In the clinical development, we aim to demonstrate the following:
1. Determination of the therapeutic dose(s) to be used in the expansion phase.
2. Demonstration of the safety and tolerability of 177Lu-LNC1003 at therapeutic doses.
The treatment regimen will consist of a single-dose intravenous administration of 177Lu-LNC1003 Injection per 6-week cycle, for a total of 2 cycles. The dose per cycle will be fixed for each patient and will be escalated in 3 different dose levels

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.

This study is a single-arm, single-center trial aimed at evaluating the pharmacokinetics, bio-distribution, dosimetry, and safety of 18F-LNC1007 injection in healthy volunteers and light tumor burden cancer patients, as defined by <5 lesions on a conventional PET/CT done for clinical purposes and molecular imaging tumor volume of <10ml.
All participants must provide a signed consent form before enrolling in the trial.
For each participant, the study duration will be about 3 weeks including 2 weeks' screening, 1 week of scanning and safety follow-up.