Prostate CancerEarly Phase 1NCT07542379
The Safety, Dosimetry and Efficacy of 177Lu-FC516 in Patients With Prostate Cancer
A Early Phase 1 study testing 177Lu-FC516 in people with Prostate Cancer, run by FindCure Biosciences (ZhongShan) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 177Lu-FC516
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to Oct 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu
Chunjing Yu, 0510-88682999, ycjwxd1978@jiangnan.edu.cn
About this study
Official title: Evaluation of the Safety, Dosimetry and Efficacy of 177Lu-FC516 Injection in Patients With Prostate Cancer
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
- Being tested
- 177Lu-FC516
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-FC516Drug
The drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-FC516 injection | Experimental | Not described Receives: Drug: 177Lu-FC516 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine dose-limiting toxicity (DLT)
Determine the DLT of FC516
Measured: 42 days after first dose
Frequency of adverse events (AEs) and SAEs
To investigate the safety characteristics of FC516
Measured: Approximately 12 months
Determine the Maximum Tolerated Dose (MTD)
Determine the MTD of FC516
Measured: Approximately 12 months
Secondary outcomes (3)
Objective response rate (ORR)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1
Measured: Approximately 12 months
Progression free survival (PFS)
PFS as assessed using RECIST 1.1
Measured: Approximately 12 months
Disease control rate (DCR)
DCR as assessed using RECIST 1.1
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start31 Aug 2026
- Primary completionMay 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Affiliated Hospital of Jiangnan University
- Responsible party
- Sponsor
- Investigators
- Chunjing Yu, Principal investigator, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542379
- Sponsor's protocol ID
- FC516-IIT-TR-02
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety, Dosimetry and Efficacy of 177Lu-FC516 Injection in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT07542379
- Acronym / sponsor ID
- FC516-IIT-TR-02
- Conditions
- Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Affiliated Hospital of Jiangnan University
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 177Lu-FC516 injection | Experimental | Drug: 177Lu-FC516 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lu-FC516The drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles. | Drug | 177Lu-FC516 injection |
Primary outcome
Determine dose-limiting toxicity (DLT)
Time frame: 42 days after first dose
Determine the DLT of FC516
Frequency of adverse events (AEs) and SAEs
Time frame: Approximately 12 months
To investigate the safety characteristics of FC516
Determine the Maximum Tolerated Dose (MTD)
Time frame: Approximately 12 months
Determine the MTD of FC516
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chunjing Yu principal investigator
Affiliated Hospital of Jiangnan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 177Lu-FC516 in people with Prostate Cancer, run by FindCure Biosciences (ZhongShan) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tingjin Wang (18664044814, wangtingjin@find-cure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine dose-limiting toxicity (DLT) (time frame: 42 days after first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.