Lu-177 FC516 safety and dosimetry in metastatic castration-resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a early-phase, single-arm, open-label, dose-escalation study in adults with metastatic castration-resistant prostate cancer. Five predefined dose groups are evaluated, with treatment given every 6 weeks for up to four cycles. After each dose group completes enrollment and observes safety, radiation dosimetry, and preliminary efficacy, the next group's dose may be adjusted or escalation stopped. The goal is to establish safety, determine dosimetry, and obtain initial signals of efficacy for Lu-177 FC516. Participants must meet specific laboratory and performance criteria and have at least one measurable lesion per RECIST 1.1.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Chunjing Yu — Affiliated Hospital of Jiangnan University
• Study coordinator: Tingjin Wang
• Email: wangtingjin@find-cure.com
• Phone: 18664044814

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.