RECRUITING

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

Conditions

Metastatic Castration-resistant Prostate Cancer Safety RP2D Pharmacokinetics Dosimetry Preliminary efficacy Dose escalation Dose expansion PSMA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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.

Quick Facts

Study Start:2024-08-30

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06492122

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Full-Life Technologies GmbH

CONTACT

+49 6221 648 4000

clinicaltrials@t-full.com

Principal Investigator

Full-Life Technologies GmbH

STUDY_DIRECTOR

Full-Life Technologies GmbH

Study Locations (Sites)

City of Hope Medical Center

Duarte, California, 91010

United States

University of Stanford

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: Full-Life Technologies GmbH

Full-Life Technologies GmbH, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-08-30

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-08-30

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Safety
RP2D
Pharmacokinetics
Dosimetry
Preliminary efficacy
Dose escalation
Dose expansion
PSMA

Additional Relevant MeSH Terms

Metastatic Castration-resistant Prostate Cancer