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

May 21, 2026 updated by: Full-Life Technologies GmbH

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.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this Phase 1, First-in-Human, Open-label Trial is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of [225Ac]Ac-FL-020 as a single agent in participants with metastatic Castration-Resistant Prostate Cancer (mCRPC). [111In]In-FL-020 serves as a surrogate for 225Ac-FL-020 for dosimetry purposes. The trial is divided into two parts: dose escalation in Part 1 and cohort expansion in Part 2.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Brisbane, Australia
        • Recruiting
        • Princess Alexandra Hospital
        • Principal Investigator:
          • Aaron Hansen, MD
        • Contact:
          • Gillian Jagger
      • Murdoch, Australia
        • Recruiting
        • GenesisCare Murdoch
        • Contact:
          • Vicki Sproule
        • Principal Investigator:
          • Joe Cardaci, MD
      • Sydney, Australia, NSW 2109
        • Recruiting
        • MacQuarie University Clinical Trial Unit
        • Contact:
          • Luke Wood, Clinical Trial Coordinator
          • Phone Number: +61 434 971 076
          • Email: luke.wood@mq.edu.au
        • Principal Investigator:
          • Howard Gurney, Professor
  • China
      • Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Zhi Yang, Professor
        • Sub-Investigator:
          • Peng Du, MD
      • Shanghai, China, 200002
        • Recruiting
        • Renji Shanghai Hospital
        • Contact:
        • Principal Investigator:
          • Wei Xu, MD
        • Principal Investigator:
          • Jianjun Liu, MD
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06590
        • Recruiting
        • Ankara Üniversitesi Tıp Fakültesi Cebeci Hastanesi Nükleer Tıp Anabilim Dalı
        • Principal Investigator:
          • Yuksel Urun
        • Contact:
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Medical Center
        • Principal Investigator:
          • Jeffrey Wong, MD
        • Contact:
          • Jennifer Simpson
      • Irvine, California, United States, 92612
        • Recruiting
        • Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Shyam Srinivas, MD
      • Stanford, California, United States, 94305
        • Recruiting
        • University of Stanford
        • Principal Investigator:
          • Hong Song, MD
        • Principal Investigator:
          • Andrei Iagaru, MD
        • Contact:
          • David G. Marcellus
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospital of Cleveland
        • Principal Investigator:
          • Pedro Barata, MD
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Cancer Center
        • Contact:
          • Robert Dreicer, Principal Investigator
          • Phone Number: +1 434-924-1775
          • Email: rd7va@UVAHealth.org
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: [225Ac]Ac-FL-020
Treatment with [225Ac]Ac-FL-020 administered intravenously. 10 patients will also receive [111In]In-FL-020 for dosimetry purposes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose escalation: Incidence of Dose-Limiting Toxicities (DLTs).
Time Frame: 28 days after the first injection of [225Ac]Ac-FL-020
RP2D
28 days after the first injection of [225Ac]Ac-FL-020
Dose escalation and dose expansion: Type, frequency and severity of adverse events (AEs) and serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time Frame: From ICF signature and up to 42 days after the last dose of study treatment for all AE and SAE. Then only the AE/SAE suspected to be related to the study treatment will be reported.
From ICF signature and up to 42 days after the last dose of study treatment for all AE and SAE. Then only the AE/SAE suspected to be related to the study treatment will be reported.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dose escalation and dose expansion: Absorbed doses
Time Frame: During one week following the injection of [111In]In-FL-020
Absorbed doses in different organs and tumors
During one week following the injection of [111In]In-FL-020
Peak Plasma Concentration (Cmax)
Time Frame: During one week following the first injection of [225Ac]Ac-FL-020
Pharmacokinetics
During one week following the first injection of [225Ac]Ac-FL-020
Area Under the Plasma concentration versus time curve
Time Frame: During one week following the first injection of [225Ac]Ac-FL-020
Pharmacokinetics
During one week following the first injection of [225Ac]Ac-FL-020
Overall response rate
Time Frame: 2 years
Anti-tumor activity via imaging assessments and PSA levels
2 years
Disease Control Rate
Time Frame: 2 years
Anti-tumor activity via imaging assessments and PSA levels
2 years
Best Overall response
Time Frame: 2 years
Anti-tumor activity via imaging assessments and PSA levels
2 years
Progression Free Survival
Time Frame: 2 years
Anti-tumor activity via imaging assessments and PSA levels
2 years
Overall Survival
Time Frame: 2 years
Anti-tumor activity
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Full-Life Technologies GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Full-Life Technologies GmbH, Full-Life Technologies GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FL-020-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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