Evaluating Safety and Effectiveness of 177Lu-JH04 Treatment for Patients with Advanced FAP-Positive Tumors

What this Trial Is About

Researchers are evaluating the use of 177Lu-JH04, a new radiopharmaceutical targeting fibroblast activation protein FAP, in patients with advanced metastatic tumors that show high FAP expression. This pilot study aims to assess the dosimetry, toxicity, and treatment response of 177Lu-JH04 after other treatment options have been exhausted. FAP is a marker found abundantly in the tumor environment of many cancers, making it a promising target for diagnosis and therapy. Participants are divided into three groups of three patients each, receiving different doses of 177Lu-JH04 intravenously approximately 3.70 GBq 100 mCi, 5.55 GBq 150 mCi, and 7.40 GBq 200 mCi. Each patient receives a single dose of the assigned amount, with up to four cycles of treatment. The study involves careful monitoring of the effects and distribution of the drug in the body. During the study, patients undergo evaluations to measure toxic effects and side effects over about two weeks. Dosimetry assessments of normal organs and tumors are conducted over approximately four weeks. Researchers use imaging and laboratory tests to monitor kidney, blood, and liver function, as well as overall health status. The total participation duration varies according to treatment cycles and follow-up assessments, with safety and response data collected throughout.

177Lu-JH04 in Patients with FAP-Positive Tumors