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

April 14, 2026 updated by: FindCure Biosciences (ZhongShan) Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

13

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Wuxi, Jiangsu, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged >=18 years old.
  2. Patients with metastatic castration-resistant prostate cancer who have failed standard treatments.
  3. According to RECIST 1.1, there is at least one measurable lesion.
  4. ECOG performance status 0-1.
  5. Laboratory examination should meet: ① Blood routine: hemoglobin (HGB) ≥90g/L, neutrophil count (ANC) ≥1.5×10^9/L, platelet count ( PLT) ≥100×10^9/L; ②Blood biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN, serum creatinine ( Cr)≤1.5×ULN or calculate the creatinine clearance ≥50 mL/min according to the Cockcroft-Gault formula method.

Exclusion Criteria:

  1. Received anti-tumor therapy within 4 weeks before enrollment.
  2. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
  3. Have undergone surgery within 4 weeks before enrollment.
  4. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
  5. Central nervous system metastases with clinical symptoms.
  6. With any situations that the researcher considers inappropriate to participate in this research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 177Lu-FC516 injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine dose-limiting toxicity (DLT)
Time Frame: 42 days after first dose
Determine the DLT of FC516
42 days after first dose
Frequency of adverse events (AEs) and SAEs
Time Frame: Approximately 12 months
To investigate the safety characteristics of FC516
Approximately 12 months
Determine the Maximum Tolerated Dose (MTD)
Time Frame: Approximately 12 months
Determine the MTD of FC516
Approximately 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Approximately 12 months
To explore the clinical effectiveness. Tumor response based on RECIST 1.1
Approximately 12 months
Disease control rate (DCR)
Time Frame: Approximately 12 months
DCR as assessed using RECIST 1.1
Approximately 12 months
Progression free survival (PFS)
Time Frame: Approximately 12 months
PFS as assessed using RECIST 1.1
Approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FindCure Biosciences (ZhongShan) Co., Ltd.

Collaborators

Affiliated Hospital of Jiangnan University

Investigators

  • Principal Investigator: Chunjing Yu, Affiliated Hospital of Jiangnan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FC516-IIT-TR-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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