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

NCT06492122 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: FL-020-001
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 9

Brief 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).

Conditions

Metastatic Castration-resistant Prostate Cancer

Keywords

Safety; RP2D; Pharmacokinetics; Dosimetry; Preliminary efficacy; Dose escalation; Dose expansion; PSMA; mCRPC; Prostate; Radiopharmaceutical; RDC; Phase I; Actinium-225; Full-Life; RLT; ProTACT

Outcome Measures

Primary Outcomes (2)

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

  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.

  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)

• Dose escalation and dose expansion: Absorbed doses

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

• Peak Plasma Concentration (Cmax)

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

• Area Under the Plasma concentration versus time curve

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

• Overall response rate

  2 years

• Disease Control Rate

  2 years

Study Arms (1)

[225Ac]Ac-FL-020

EXPERIMENTAL

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; Drug: Blood samples for PK; Drug: [111In]In-FL-020; Procedure: Blood and urine samples collection; Procedure: SPECT/CT images

Interventions

[225Ac]Ac-FL-020 DRUG

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

[225Ac]Ac-FL-020

[111In]In-FL-020 DRUG

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

[225Ac]Ac-FL-020

Blood and urine samples collection PROCEDURE

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

[225Ac]Ac-FL-020

SPECT/CT images PROCEDURE

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

[225Ac]Ac-FL-020

Blood samples for PK DRUG

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

[225Ac]Ac-FL-020

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients are male with mCRPC
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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,

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Full-Life Technologies GmbH: lead

Study Sites (9)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

Chao Family Comprehensive Cancer Center

Irvine, California, 92612, United States

RECRUITING

University of Stanford

Stanford, California, 94305, United States

RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, 22903, United States

RECRUITING

Princess Alexandra Hospital

Brisbane, Australia

RECRUITING

Genesiscare Murdoch

Murdoch, Australia

RECRUITING

MacQuarie University Clinical Trial Unit

Sydney, NSW 2109, Australia

RECRUITING

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

Ankara Üniversitesi Tıp Fakültesi Cebeci Hastanesi Nükleer Tıp Anabilim Dalı

Ankara, 06590, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Full-Life Technologies GmbH

  Full-Life Technologies GmbH

  STUDY DIRECTOR

Central Study Contacts

Full-Life Technologies

CONTACT

+1 973-727-3254; clinicaltrials@t-full.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation and dose expansion

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 9, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2025-09

Locations

TU (1); CN (1); US (4); AU (3)