Prostate Cancer
Conditions
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.
Interventions
DRUG177Lu-FC516
The drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles.
Sponsors
FindCure Biosciences (ZhongShan) Co., Ltd.
Affiliated Hospital of Jiangnan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Approximately 12 months | To explore the clinical effectiveness. Tumor response based on RECIST 1.1 |
| Progression free survival (PFS) | Approximately 12 months | PFS as assessed using RECIST 1.1 |
| Disease control rate (DCR) | Approximately 12 months | DCR as assessed using RECIST 1.1 |
Countries
China
Contacts
CONTACTTingjin Wang
PRINCIPAL_INVESTIGATORChunjing Yu
Affiliated Hospital of Jiangnan University
Outcome results
None listed