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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Study With [225Ac]Ac-FL-020 in mCRPC Participants

A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of [225Ac]Ac-FL-020 in Participants With mCRPC.

Study With [225Ac]Ac-FL-020 in mCRPC Participants (NCT06492122) is a Phase 1 interventional studying Metastatic Castration-resistant Prostate Cancer, sponsored by Full-Life Technologies UK Limited. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to evaluate the safety, therapeutic effect, and pharmacokinetics of \[225Ac\]Ac-FL-020 in participants with metastatic castration-resistant prostate cancer (mCRPC).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Metastatic Castration-resistant Prostate Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 50 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Metastatic Castration-resistant Prostate Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-confirmed) metastatic CRPC. 2. Age ≥ 18 years. 3. Signed willing to sign a consent form, and able and willing to comply with protocol requirements prior to any study procedures. 4. Patients must have a life expectancy \>3 months. 5. All patients are required to have one or more positive lesions detected by PSMA-PET/CT scan 6. Documented progression of the disease based on the Investigator judgement 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 8. Have a castrate serum testosterone \< 50 ng/dL or \<1.7 nmol/L. Patients must continue primary androgen deprivation with an LHRH analogue (agonist/antagonist) if they have not undergone bilateral orchiectomy. 9. Have previously been treated with at least one of the following: 1. Androgen receptor signaling inhibitor (such as enzalutamide). 2. CYP 17 inhibitor (such as abiraterone acetate). 10. Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. Note: In cases where patients are unwilling to undergo taxane therapy due to concerns regarding its potential toxicity, enrollment of patients previously not treated with taxane might be considered after careful evaluation by the investigator. In such cases, patients will be fully informed about the potential benefits of taxane therapy, including its role in prolonging survival. 11. your organs (liver, kidneys, etc.) are working well enough based on blood tests as defined by: 1. Absolute neutrophil count (ANC) ≥2 x 10\^9/L (2000/µL), 2. blood count (hemoglobin) at least 9.0 g/dL, 3. platelet count at least 90 x 10\^9/L (90 000/µL), 4. Serum albumin \>3g/dL 5. Aspartate aminotransferase (AST) ≤2.5 x ULN; alanine aminotransferase (ALT) ≤2.5 x ULN (AST, ALT ≤5 x ULN if liver metastases are present), 6. Serum total bilirubin ≤1.5 x ULN (≤5 x ULN if liver metastases present) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Histologically or cytologically confirmed metastatic CRPC. 2. Age ≥ 18 years. 3. Signed informed consent, and able and willing to comply with protocol requirements prior to any study procedures. 4. Patients must have a life expectancy \>3 months. 5. All patients are required to have one or more positive lesions detected by PSMA-PET/CT scan 6. Documented progression of the disease based on the Investigator judgement 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 8. Have a castrate serum testosterone \< 50 ng/dL or \<1.7 nmol/L. Patients must continue primary androgen deprivation with an LHRH analogue (agonist/antagonist) if they have not undergone bilateral orchiectomy. 9. Have previously been treated with at least one of the following: 1. Androgen receptor signaling inhibitor (such as enzalutamide). 2. CYP 17 inhibitor (such as abiraterone acetate). 10. Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. Note: In cases where patients are unwilling to undergo taxane therapy due to concerns regarding its potential toxicity, enrollment of patients previously not treated with taxane might be considered after careful evaluation by the investigator. In such cases, patients will be fully informed about the potential benefits of taxane therapy, including its role in prolonging survival. 11. Adequate organ function as defined by: 1. Absolute neutrophil count (ANC) ≥2 x 10\^9/L (2000/µL), 2. Hemoglobin ≥9.0 g/dL, 3. Platelets ≥90 x 10\^9/L (90 000/µL), 4. Serum albumin \>3g/dL 5. Aspartate aminotransferase (AST) ≤2.5 x ULN; alanine aminotransferase (ALT) ≤2.5 x ULN (AST, ALT ≤5 x ULN if liver metastases are present), 6. Serum total bilirubin ≤1.5 x ULN (≤5 x ULN if liver metastases present) 7. Creatinine clearance ≥60 mL/min calculated using a standard Cockcroft and Gault formula. 8. Q wave to T wave (QT) interval corrected for heart rate (QTc) \<470 ms Exclusion Criteria: 1. Patients with known brain metastases. 2. Grade 3 Cystitis infective and non-infective. 3. Severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the study treatment administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for enrollment in this study. 4. More than 1 prior treatment with PSMA-targeted radioconjugate. 5. Previous treatment with Actinium-225, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, or hemi-body irradiation or any other radionuclide therapy except \[177Lu\]Lu-PSMA-617 and Radium-223. 6. Radium-223 within 6 months prior to the first study treatment administration. 7. Prior radioconjugate treatment within 6 weeks prior to first study treatment administration. Adverse events from prior radioconjugate treatment must be resolved or reduced to grade 1 prior to the first study treatment administration. 8. More than 6 administrations of previous radioconjugate treatment. 9. Any systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\]) within 6 weeks prior to the first study treatment administration. Patients on a stable bisphosphonate or denosumab regimen for 30 days prior to first study treatment administration are eligible. 10. Evidence of superscan in the baseline bone scan. 11. Any investigational agents within 6 weeks prior to the first study treatment administration. 12. Radiotherapy: external beam radiotherapy that encompasses \>30% of bone marrow completed less than 6 weeks or focal radiation completed less than 2 weeks, prior to the first study treatment administration. 13. Major surgery (not including placement of vascular access device or tumor biopsies) within 6 weeks prior to first dose of the study treatment, or no recovery from side effects of such intervention. 14. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. 15. Known hypersensitivity to the components of the study therapy or its analogs. 16. Enrollment in another interventional clinical study. 17. Any persistent xerostomia or dry eyes from previous treatment 18. Persistent prior AEs \> Grade 1 from prior anti-cancer therapies. 19. Significant cardiac disease, such as recent (within six months prior to first dose of the study treatment) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias, severe aortic stenosis. 20. History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within 6 months prior to first dose of the study treatment. 21. Known active infection requiring therapy, including known active infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or SARS-CoV-2 22. Prior history of malignancy other than inclusion diagnosis within three years prior to first dose of the study treatment 23. Known history of myelodysplastic syndrome.

Treatments Being Tested

DRUG

[225Ac]Ac-FL-020

\[225Ac\]Ac-FL-020 injected intravenously

DRUG

Blood samples for PK

Following the first injection of \[225Ac\]Ac-FL-020, blood samples after treatment will be collected for PK evaluation.

DRUG

[111In]In-FL-020

A dose of \[111In\]In-FL-020 will be injected prior to the first dose of \[225Ac\]Ac-FL-020 for dosimetry evaluation

PROCEDURE

Blood and urine samples collection

For dosimetry evaluation and urine excretion assessment, blood and urine samples will be collected after the injection of \[111In\]In-FL-020

PROCEDURE

SPECT/CT images

For dosimetry evaluation, SPECT/CTs will be performed following the injection of \[111In\]In-FL-020.

Locations (11)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

City of Hope Medical Center
Duarte, California, United States
Chao Family Comprehensive Cancer Center
Irvine, California, United States
University of Stanford
Stanford, California, United States
University Hospital of Cleveland
Cleveland, Ohio, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Princess Alexandra Hospital
Brisbane, Australia
Genesiscare Murdoch
Murdoch, Australia
MacQuarie University Clinical Trial Unit
Sydney, Australia
Beijing Cancer Hospital
Beijing, China
Renji Shanghai Hospital
Shanghai, China
Ankara Üniversitesi Tıp Fakültesi Cebeci Hastanesi Nükleer Tıp Anabilim Dalı
Ankara, Turkey (Türkiye)

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06492122), the sponsor (Full-Life Technologies UK Limited), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06492122 clinical trial studying?

The purpose of this study is to evaluate the safety, therapeutic effect, and pharmacokinetics of \[225Ac\]Ac-FL-020 in participants with metastatic castration-resistant prostate cancer (mCRPC). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06492122?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06492122?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06492122. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06492122. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.