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.

Trial Details

NCT ID
NCT07542379
Phase
EARLY_PHASE1
Sponsor
FindCure Biosciences (ZhongShan) Co., Ltd.
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • 177Lu-FC516
Locations (sample)
  • Wuxi, Jiangsu, China|31.56887,120.28857

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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