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

Starting soon · Early Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT07542379

Run by

FindCure Biosciences (ZhongShan) Co., Ltd.

People needed

13

Starts

2026-04-01

Expected to finish

2027-10-01

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Affiliated Hospital of Jiangnan University — Wuxi, Jiangsu, China

Full record on ClinicalTrials.gov

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