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NCT Number: NCT07542379

The Safety, Dosimetry and Efficacy of 177Lu-FC516 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged >=18 years old.
  • Patients with metastatic castration-resistant prostate cancer who have failed standard treatments.
  • According to RECIST 1.1, there is at least one measurable lesion.
  • ECOG performance status 0-1.
  • 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

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

Treatment and study plan

177Lu-FC516

Drug

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

Primary outcomes

  1. Determine dose-limiting toxicity (DLT)

    Time frame: 42 days after first dose

    Determine the DLT of FC516

  2. Frequency of adverse events (AEs) and SAEs

    Time frame: Approximately 12 months

    To investigate the safety characteristics of FC516

  3. Determine the Maximum Tolerated Dose (MTD)

    Time frame: Approximately 12 months

    Determine the MTD of FC516

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Approximately 12 months

    To explore the clinical effectiveness. Tumor response based on RECIST 1.1

  2. Progression free survival (PFS)

    Time frame: Approximately 12 months

    PFS as assessed using RECIST 1.1

  3. Disease control rate (DCR)

    Time frame: Approximately 12 months

    DCR as assessed using RECIST 1.1

Study contacts

Contact information is provided by the study sponsor or research team.

Tingjin Wang

CONTACT

[email protected]

18664044814

Sponsors and collaborators

Lead sponsor

FindCure Biosciences (ZhongShan) Co., Ltd.

Industry

Collaborators

  • Affiliated Hospital of Jiangnan University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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