The Safety, Dosimetry and Efficacy of 177Lu-FC516 in Patients With Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 177Lu-FC516.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of the Safety, Dosimetry and Efficacy of 177Lu-FC516 Injection in Patients With Prostate Cancer
Overview
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.
Interventions
- Drug 177Lu-FC516
The drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles.
Primary outcome measures
- Determine dose-limiting toxicity (DLT) [Time frame: 42 days after first dose]
- Frequency of adverse events (AEs) and SAEs [Time frame: Approximately 12 months]
- Determine the Maximum Tolerated Dose (MTD) [Time frame: Approximately 12 months]
Secondary outcome measures (3)
- Objective response rate (ORR) [Time frame: Approximately 12 months]
- Progression free survival (PFS) [Time frame: Approximately 12 months]
- Disease control rate (DCR) [Time frame: Approximately 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Affiliated Hospital of Jiangnan University — Wuxi
Identifiers
NCT: NCT07542379 · FC516-IIT-TR-02