A First-in-Human Study of ¹⁷⁷Lu-HX02 in Sarcoma Patients

This is a single-center, open-label clinical study to evaluate the safety, biodistribution, and dosimetry of ¹⁷⁷Lu-HX02 injection in patients with sarcoma. Approximately 6 to 10 subjects with sarcoma (preferably soft tissue sarcoma and Ewing's sarcoma), confirmed by histopathology, cytology, or clinical diagnosis, and with measurable lesions according to RECIST 1.1, are planned to be enrolled. The enrollment requires that at least one measurable lesion has an SUVmax ≥ 3.5 on ⁶⁸Ga-HX01 injection imaging. Eligible subjects who meet the inclusion/exclusion criteria will receive a single intravenous administration of ¹⁷⁷Lu-HX02 injection, followed by SPECT/CT imaging to assess the safety, biodistribution, and dosimetry of the drug. The study consists of two phases: a screening phase with ⁶⁸Ga-HX01 and a treatment/evaluation phase with ¹⁷⁷Lu-HX02.