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

NCT07542379 | Not Yet Recruiting Early Phase 1

• 1 other identifier: FC516-IIT-TR-02
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Determine dose-limiting toxicity (DLT)

  Determine the DLT of FC516

  42 days after first dose

• Frequency of adverse events (AEs) and SAEs

  To investigate the safety characteristics of FC516

  Approximately 12 months

• Determine the Maximum Tolerated Dose (MTD)

  Determine the MTD of FC516

  Approximately 12 months

Secondary Outcomes (3)

• Objective response rate (ORR)

  Approximately 12 months

• Progression free survival (PFS)

  Approximately 12 months

• Disease control rate (DCR)

  Approximately 12 months

Study Arms (1)

177Lu-FC516 injection

EXPERIMENTAL

Drug: 177Lu-FC516

Interventions

177Lu-FC516 DRUG

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

177Lu-FC516 injection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• FindCure Biosciences (ZhongShan) Co., Ltd.: lead
• Affiliated Hospital of Jiangnan University: collaborator

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Chunjing Yu

  Affiliated Hospital of Jiangnan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingjin Wang

CONTACT

18664044814; wangtingjin@find-cure.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

CN (1)