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COMPLETED
NCT07847268

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

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

9

Start Date

2025-03-01

Completion Date

2025-12-31

Last Updated

2026-09-29

Healthy Volunteers

Yes

Conditions

Interventions

DIAGNOSTIC_TEST

Safety, Biodistribution, and Dosimetry of ¹⁷⁷Lu-HX02 in Patients with Sarcoma

Subjects who meet the inclusion/exclusion criteria will receive an intravenous administration of ¹⁷⁷Lu-HX02 injection, followed by SPECT/CT imaging to evaluate the safety, biodistribution, and dosimetry of the drug.

Locations (1)

Wuhan Union Hospital

Wuhan, Hubei, China