RecruitingPhase 1

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.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests [225Ac]Ac-FL-020 in adults with prostate cancer that has spread and keeps growing despite very low testosterone levels. It checks the treatment’s safety, how well it works, and how it moves through the body.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, with prostate cancer confirmed by a tissue or cell test that has spread and resists treatment to lower testosterone.
  • Sign a consent form, be willing and able to follow study rules, and be expected to live more than 3 months.
  • Have at least one cancer spot found on a PSMA-PET/CT scan and cancer that is getting worse, as judged by the study doctor.
  • Be fully active or able to do light work, with limits only on hard physical activity.
  • Have testosterone below 50 ng/dL. Keep taking medicine to lower testosterone unless both testicles have been removed.
  • Have had at least one treatment such as enzalutamide or abiraterone.
  • Have had 1 or 2 courses of taxane chemotherapy. The doctor may consider people who declined it because of side effect concerns, after explaining its possible benefits.
  • Meet the study’s blood count, liver, kidney, blood protein, and heart rhythm test limits.

Who can't join

  • Cancer in the brain; severe bladder swelling or infection; pressure or signs of coming pressure on the spinal cord; or a bone scan showing a widespread pattern called a superscan.
  • More than 1 past PSMA-targeted radioactive drug treatment, or more than 6 doses of past radioactive drug treatment. Past radioactive treatments other than [177Lu]Lu-PSMA-617 or radium-223, or radiation to half the body, also exclude you.
  • Radium-223 within 6 months; radioactive drug treatment, whole-body cancer medicines, or experimental drugs within 6 weeks. Stable bisphosphonate or denosumab treatment for 30 days is allowed.
  • Radiation covering more than 30% of bone marrow within 6 weeks, focused radiation within 2 weeks, or major surgery within 6 weeks. Port placement and tumor biopsies do not count as major surgery.
  • Lasting side effects worse than mild from past cancer treatment, lasting dry mouth or dry eyes, or not recovering from surgery. Allergy to the study drug’s ingredients or similar drugs, or joining another treatment study, also excludes you.
  • Serious heart disease, uncontrolled blood pressure or heart rhythm, or a heart attack or sudden heart blood-flow problem within 6 months. A stroke, mini-stroke, or blood clot within 6 months also excludes you.
  • An active infection needing treatment, including active HIV, hepatitis B, hepatitis C, or COVID-19; another cancer within 3 years; or a history of myelodysplastic syndrome, a bone marrow disease.
  • Other serious physical or mental health problems, or abnormal lab results, that the study doctor thinks could make participation unsafe or affect the study results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (5)

CA

  • City of Hope Medical Center · Duarte, CA 91010Jennifer Simpson · Study contactJeffrey Wong, MD · Principal investigatorMore trials in Duarte
  • Chao Family Comprehensive Cancer Center · Irvine, CA 92612Amanda Macaraeg · Study contact · 714-456-8000 · macaraeg@hs.uci.eduShyam Srinivas, MD · Principal investigatorMore trials in Irvine
  • University of Stanford · Stanford, CA 94305David G. Marcellus · Study contactAndrei Iagaru, MD · Principal investigatorHong Song, MD · Principal investigatorMore trials in Stanford

OH

VA