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

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

NCT ID: NCT06492122

Condition: Metastatic Castration-resistant Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
Safety
RP2D
Pharmacokinetics
Dosimetry
Preliminary efficacy
Dose escalation
Dose expansion
PSMA

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Dose escalation and dose expansion

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: [225Ac]Ac-FL-020
Description: [225Ac]Ac-FL-020 injected intravenously
Arm group label: [225Ac]Ac-FL-020

Intervention type: Drug
Intervention name: Blood samples for PK
Description: Following the first injection of [225Ac]Ac-FL-020, blood samples after treatment will be collected for PK evaluation.
Arm group label: [225Ac]Ac-FL-020

Intervention type: Drug
Intervention name: [111In]In-FL-020
Description: A dose of [111In]In-FL-020 will be injected prior to the first dose of [225Ac]Ac-FL-020 for dosimetry evaluation
Arm group label: [225Ac]Ac-FL-020

Intervention type: Procedure
Intervention name: Blood and urine samples collection
Description: For dosimetry evaluation and urine excretion assessment, blood and urine samples will be collected after the injection of [111In]In-FL-020
Arm group label: [225Ac]Ac-FL-020

Intervention type: Procedure
Intervention name: SPECT/CT images
Description: For dosimetry evaluation, SPECT/CTs will be performed following the injection of [111In]In-FL-020.
Arm group label: [225Ac]Ac-FL-020

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).

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.

Criteria for 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. All patients are required to have one or more positive lesions detected by PSMA-PET/CT scan 5. Documented progression of the disease based on the Investigator judgement 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 7. 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. 8. 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). 9. Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. 10. Adequate organ function as defined by: 1. Absolute neutrophil count (ANC) ≥2 x 10^9/L (2000/µL), 2. Hemoglobin ≥10.0 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. ALP ≤2.5 x ULN (ALP ≤5.0 x ULN, if liver or bone metastases are present), 7. Serum total bilirubin ≤1.5 x ULN (≤5 x ULN if liver metastases present) 8. Creatinine clearance ≥60 mL/min calculated using a standard Cockcroft and Gault formula. 9. 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. 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 or Radium-223. 5. Radium-223 within 6 months prior to the first study treatment administration. 6. [177Lu]-Lu-PSMA-617 within 6 weeks prior to first study treatment administration. Adverse events related to [177Lu]Lu-PSMA-617 are required to be either resolved or of grade 1 prior to the first study treatment administration. 7. 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. 8. Any investigational agents within 6 weeks prior to the first study treatment administration. 9. 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. 10. 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. 11. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. 12. Known hypersensitivity to the components of the study therapy or its analogs. 13. Enrollment in another interventional clinical study. 14. Known history of myelodysplastic syndrome.

Gender: Male

Gender based: Yes

Gender description: Patients are male with mCRPC

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Genesiscare Murdoch

Address:
City: Murdoch
Country: Australia

Status: Recruiting

Contact:
Last name: Vicki Sproule

Investigator:
Last name: Joe Cardaci, MD
Email: Principal Investigator

Start date: October 2024

Completion date: December 2026

Lead sponsor:
Agency: Full-Life Technologies GmbH
Agency class: Industry

Source: Full-Life Technologies GmbH

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06492122