Phase 1 Study to Evaluate Safety and Tolerability of 68Ga-NRT6020 and 177Lu-NRT6020 Injections in Adults With FAP-Positive Advanced Solid Tumors

What this Trial Is About

Researchers are investigating the safety and effectiveness of two investigational drugs, 68Ga-NRT6020 Injection and 177Lu-NRT6020 Injection, in people with advanced solid tumors that have not responded to standard treatments or for whom no standard options exist. The study is divided into three stages the first focuses on safety and imaging comparisons, the second on safety and tolerability in patients with a specific marker FAP-positive, and the third on finding the recommended dose and early signs of the drugs effects. This trial is sponsored by Chengdu New Radiomedicine Technology Co. LTD. During stage 1, participants receive a single intravenous dose of 68Ga-NRT6020 Injection at either a low or high dose, followed by PETCT scans to assess drug distribution and imaging characteristics. Stage 2 involves multiple doses of 177Lu-NRT6020 Injection administered every six weeks or as determined by the safety review committee, with dose escalation to identify the best dose, alongside ongoing 68Ga-NRT6020 use. Stage 3 continues with multiple doses of 177Lu-NRT6020 Injection to confirm the recommended dose and assess preliminary efficacy, while also monitoring imaging and pharmacokinetics. Participants undergo various assessments throughout the study, including PETCT imaging, blood tests to measure drug levels and radiation doses, and evaluations of tumor response and safety over about one year. Researchers track side effects, dose limits, and how the drugs move through the body. The study includes regular monitoring of adverse events and treatment responses, and participants must meet specific health and tumor criteria to enroll.

Safety Trial of 68Ga/177Lu-NRT6020 in FAP-Positive Advanced Solid Tumor Patients