Phase 1 Study of 177Lu-FC516 for Prostate Cancer
Summary
NIH registered a Phase 1 dose-escalation study (NCT07542379) evaluating 177Lu-FC516 in patients with prostate cancer. The single-arm, open-label trial enrolled 5 pre-defined dose groups, with drug administered once every 6 weeks for 1 to 4 cycles. Dose escalation decisions are based on participant safety tolerance, radiation dosimetry, and preliminary efficacy results.
What changed
NIH added a clinical trial registry entry for a Phase 1 study of 177Lu-FC516 in prostate cancer. The trial is designed as a prospective, single-arm, open-label dose-escalation study with 5 pre-defined dose groups. Participants receive the drug once every 6 weeks for 1 to 4 cycles, with dose adjustments based on safety and efficacy assessments after each group completes DLT observation.
Pharmaceutical sponsors and clinical investigators conducting early-phase oncology trials should note this registry entry represents standard trial registration requirements under NIH policy. The study provides early safety and dosimetry data for a radiopharmaceutical intervention in prostate cancer.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
The Safety, Dosimetry and Efficacy of 177Lu-FC516 in Patients With Prostate Cancer
Early Phase 1 NCT07542379 Kind: EARLY_PHASE1 Apr 21, 2026
Abstract
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: Prostate Cancer
Interventions: 177Lu-FC516
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