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Clinical Trials in China / NCT07542379
Recruiting Early Phase 1

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

NCT07542379 · tracked via the Priya Life Science China tracker
Sponsor
FindCure Biosciences (ZhongShan) Co., Ltd
Phase
Early Phase 1
Started
2026-08-31
Last updated
2026-09-04

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

177Lu-FC516

177Lu-FC516: The drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles.

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Affiliated Hospital of Jiangnan University Wuxi Jiangsu Recruiting

More FindCure Biosciences (ZhongShan) Co., Ltd. trials in China

The Safety, Dosimetry and Efficacy of 177Lu-INN805 in Patients With Malignant Solid Tumors Recruiting
The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer Recruiting
A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors Recruiting

Other trials for the same condition

A Study of SHR-4394 Injection in Subjects With Prostate Cancer Recruiting
AI Multimodal Model for Predicting CRPC Progression Risk Active, not recruiting
Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy Active, not recruiting
Comparison of MRI Artificial Intelligence-guided cTB Versus Routine cTB in Prostate Cancer Diagnosis Recruiting
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07542379 on ClinicalTrials.gov ↗ ← All trials in China