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Metastatic Castration-resistant Prostate CancerPhase 1ProTACTNCT06492122

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

A Phase 1 study testing [225Ac]Ac-FL-020, Blood samples for PK and [111In]In-FL-020 in people with Metastatic Castration-resistant Prostate Cancer, run by Full-Life Technologies UK Limited at 11 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
[225Ac]Ac-FL-020, Blood samples for PK and [111In]In-FL-020
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
11 sitesin 4 countries
Study dates
30 Aug 2024to Sep 2027
Phase
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

  • Histologically or cytologically confirmed metastatic CRPC.
  • Age ≥ 18 years.
  • Signed informed consent, and able and willing to comply with protocol requirements prior to any study procedures.
  • Patients must have a life expectancy >3 months.
  • All patients are required to have one or more positive lesions detected by PSMA-PET/CT scan
  • Documented progression of the disease based on the Investigator judgement
Show all 21Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • 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.
  • Have previously been treated with at least one of the following:
  • Androgen receptor signaling inhibitor (such as enzalutamide).
  • CYP 17 inhibitor (such as abiraterone acetate).
  • 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.
  • Adequate organ function as defined by:
  • Absolute neutrophil count (ANC) ≥2 x 10^9/L (2000/µL),
  • Hemoglobin ≥9.0 g/dL,
  • Platelets ≥90 x 10^9/L (90 000/µL),
  • Serum albumin >3g/dL
  • Aspartate aminotransferase (AST) ≤2.5 x ULN; alanine aminotransferase (ALT) ≤2.5 x ULN (AST, ALT ≤5 x ULN if liver metastases are present),
  • Serum total bilirubin ≤1.5 x ULN (≤5 x ULN if liver metastases present)
  • Creatinine clearance ≥60 mL/min calculated using a standard Cockcroft and Gault formula.
  • Q wave to T wave (QT) interval corrected for heart rate (QTc) <470 ms

Who cannot join

  • Patients with known brain metastases.
  • Grade 3 Cystitis infective and non-infective.
  • 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.
  • More than 1 prior treatment with PSMA-targeted radioconjugate.
  • 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.
  • Radium-223 within 6 months prior to the first study treatment administration.
Show all 23Show fewer
  • 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.
  • More than 6 administrations of previous radioconjugate treatment.
  • 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.
  • Evidence of superscan in the baseline bone scan.
  • Any investigational agents within 6 weeks prior to the first study treatment administration.
  • 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.
  • 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.
  • Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
  • Known hypersensitivity to the components of the study therapy or its analogs.
  • Enrollment in another interventional clinical study.
  • Any persistent xerostomia or dry eyes from previous treatment
  • Persistent prior AEs > Grade 1 from prior anti-cancer therapies.
  • 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.
  • 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.
  • 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
  • Prior history of malignancy other than inclusion diagnosis within three years prior to first dose of the study treatment
  • Known history of myelodysplastic syndrome.

Trial locations and contacts

11 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Full-Life Technologies contact

+1 973-727-3254

clinicaltrials@t-full.com

11 sites in 4 countries

United States5 sites, 5 recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22903

    Robert Dreicer, Principal Investigator, +1 434-924-1775, rd7va@UVAHealth.org

    Christine P Martin, Clinical Trial Coordinator, cmp2p@uvahealth.org

    Recruiting

  • University Hospital of Cleveland

    Cleveland, Ohio, 44106

    Cheryl L Eitman, Clinical research Nurse, +1 216 392-6512, cheryl.eitman2@uhhospitals.org

    Pedro Barata, MD

    Recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Jennifer Simpson

    Jeffrey Wong, MD

    Recruiting

  • Chao Family Comprehensive Cancer Center

    Irvine, California, 92612

    Amanda Macaraeg, 714-456-8000, macaraeg@hs.uci.edu

    Shyam Srinivas, MD

    Recruiting

  • University of Stanford

    Stanford, California, 94305

    David G. Marcellus

    Andrei Iagaru, MD

    Recruiting

Other trials in United States

Australia3 sites, 3 recruiting

  • Princess Alexandra Hospital

    Brisbane

    Gillian Jagger

    Aaron Hansen, MD

    Recruiting

  • Genesiscare Murdoch

    Murdoch

    Vicki Sproule

    Joe Cardaci, MD

    Recruiting

  • MacQuarie University Clinical Trial Unit

    Sydney, NSW 2109

    Luke Wood, Clinical Trial Coordinator, +61 434 971 076, luke.wood@mq.edu.au

    Howard Gurney, Professor

    Recruiting

Other trials in Australia

China2 sites, 2 recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Jingjing Su, +86 02861508826, jingjingsu@pharmaron.com

    Zhi Yang, Professor

    Recruiting

  • Renji Shanghai Hospital

    Shanghai, 200002

    Vivien Hou, +86 02861508826, vivienhou@pharmaron.com

    Wei Xu, MD

    Recruiting

Other trials in China

Turkey (Türkiye)1 site, 1 recruiting

  • Ankara Üniversitesi Tıp Fakültesi Cebeci Hastanesi Nükleer Tıp Anabilim Dalı

    Ankara, 06590

    Özlem Üstündag, Clinical Trial Coordinator, +90 312 508 3879, ozlem_ustundag06@hotmail.com

    Yüksel Ürün

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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).

Read the 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.

Being tested
[225Ac]Ac-FL-020, Blood samples for PK, [111In]In-FL-020, Blood and urine samples collection, SPECT/CT images
Keywords
Safety, RP2D, Pharmacokinetics, Dosimetry, Preliminary efficacy, Dose escalation, Dose expansion, PSMA, mCRPC, Prostate, Radiopharmaceutical, RDC, Phase I, Actinium-225, Full-Life, RLT, ProTACT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [225Ac]Ac-FL-020Drug

    [225Ac]Ac-FL-020 injected intravenously

  • Blood samples for PKDrug

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

  • [111In]In-FL-020Drug

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

  • Blood and urine samples collectionProcedure or surgery

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

  • SPECT/CT imagesProcedure or surgery

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

Study groups in NCT06492122
Study groupRoleWhat they receive
[225Ac]Ac-FL-020ExperimentalTreatment with [225Ac]Ac-FL-020 administered intravenously. 10 patients will also receive [111In]In-FL-020 for dosimetry purposes.
Receives: Drug: [225Ac]Ac-FL-020; Drug: Blood samples for PK; Drug: [111In]In-FL-020; Procedure: Blood and urine samples collection; Procedure: SPECT/CT images

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose escalation: Incidence of Dose-Limiting Toxicities (DLTs).

    RP2D

    Measured: 28 days after the first injection of [225Ac]Ac-FL-020

  2. 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.

    Measured: 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 outcomes (8)

  1. Dose escalation and dose expansion: Absorbed doses

    Absorbed doses in different organs and tumors

    Measured: During one week following the injection of [111In]In-FL-020

  2. Peak Plasma Concentration (Cmax)

    Pharmacokinetics

    Measured: During one week following the first injection of [225Ac]Ac-FL-020

  3. Area Under the Plasma concentration versus time curve

    Pharmacokinetics

    Measured: During one week following the first injection of [225Ac]Ac-FL-020

  4. Overall response rate

    Anti-tumor activity via imaging assessments and PSA levels

    Measured: 2 years

  5. Disease Control Rate

    Anti-tumor activity via imaging assessments and PSA levels

    Measured: 2 years

  6. Best Overall response

    Anti-tumor activity via imaging assessments and PSA levels

    Measured: 2 years

  7. Progression Free Survival

    Anti-tumor activity via imaging assessments and PSA levels

    Measured: 2 years

  8. Overall Survival

    Anti-tumor activity

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start30 Aug 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Dose escalation and dose expansion
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06492122
Sponsor's protocol ID
FL-020-001
Acronym
ProTACT
Status last verified
May 2026
First submitted
24 Jun 2024
Last updated
26 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [225Ac]Ac-FL-020, Blood samples for PK and [111In]In-FL-020 in people with Metastatic Castration-resistant Prostate Cancer, run by Full-Life Technologies UK Limited at 11 sites in 4 countries.

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 21 inclusion and 23 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Australia, China, Turkey (Türkiye). 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Full-Life Technologies (+1 973-727-3254, clinicaltrials@t-full.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose escalation: Incidence of Dose-Limiting Toxicities (DLTs). (time frame: 28 days after the first injection of [225Ac]Ac-FL-020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06492122.

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 26 May 2026.

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