MedTrace Logo

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

NCT07542379 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-04-21

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Affiliated Hospital of Jiangnan University

    collaborator OTHER

  • FindCure Biosciences (ZhongShan) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chunjing Yu · Affiliated Hospital of Jiangnan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-05-31
Completion
2027-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07542379 on ClinicalTrials.gov