Clinical Trial · NCT07542379

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

Overview

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.

Sponsor

FindCure Biosciences (ZhongShan) Co., Ltd.

Phase

Early Phase 1

Contacts

Chunjing Yu (PRINCIPAL_INVESTIGATOR)

Tingjin Wang (CONTACT)

wangtingjin@find-cure.com

18664044814

ClinicalTrials.gov

NCT07542379

Drug / Compound

FC516

Isotope(s):

Target(s):

ACP3

Ligand Class: Small Molecules

Eligibility

Inclusion

Patients with metastatic castration-resistant prostate cancer who have failed standard treatments.
According to RECIST 1.1, there is at least one measurable lesion.

Exclusion

Central nervous system metastases with clinical symptoms.