NCT07542379RecruitingEarly phase 1
The Safety, Dosimetry and Efficacy of 177Lu-FC516 in Patients With Prostate Cancer
Evaluation of the Safety, Dosimetry and Efficacy of 177Lu-FC516 Injection in Patients With Prostate Cancer
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 31 Aug 2026
- Primary completion date
- May 2027
- Lead sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd.
- Diseases
- Prostate cancer
- NCT number
- NCT07542379
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 13
- From 31 Aug 2026 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other
- Central nervous system metastases with clinical symptoms.
- With any situations that the researcher considers inappropriate to participate in this research.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hospital of Jiangnan University Coordinator of this site? Confirm its status | Wuxi | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.