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RECRUITING
NCT07542379
EARLY_PHASE1

The Safety, Dosimetry and Efficacy of 177Lu-FC516 in Patients With Prostate Cancer

Sponsor: FindCure Biosciences (ZhongShan) Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a prospective, single-arm, open-label, dose-escalation study. A total of 5 dose groups were pre-defined in this study. The drug was administered once every 6 weeks.The drug would be administered for 1 to 4 cycles. After each dose group completed the enrollment and DLT observation, based on the participant's safety tolerance, radiation dosimetry, and preliminary efficacy evaluation results, it was decided whether to adjust the dose of the subsequent dose groups or to suspend the dose escalation.

Official title: Evaluation of the Safety, Dosimetry and Efficacy of 177Lu-FC516 Injection in Patients With Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2026-08-31

Completion Date

2027-10

Last Updated

2026-09-04

Healthy Volunteers

No

Conditions

Interventions

DRUG

177Lu-FC516

The drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles.

Locations (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China