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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06492122




Registration number
NCT06492122
Ethics application status
Date submitted
24/06/2024
Date registered
9/07/2024
Date last updated
24/09/2024

Titles & IDs
Public title
Study With [225Ac]Ac-FL-020 in mCRPC Participants
Scientific 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.
Secondary ID [1] 0 0
FL-020-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - [225Ac]Ac-FL-020
Treatment: Drugs - Blood samples for PK
Treatment: Drugs - [111In]In-FL-020
Treatment: Surgery - Blood and urine samples collection
Treatment: Surgery - SPECT/CT images

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.


Treatment: Drugs: [225Ac]Ac-FL-020
\[225Ac\]Ac-FL-020 injected intravenously

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

Treatment: Drugs: [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

Treatment: Surgery: 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

Treatment: Surgery: SPECT/CT images
For dosimetry evaluation, SPECT/CTs will be performed following the injection of \[111In\]In-FL-020.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose escalation: Incidence of Dose-Limiting Toxicities (DLTs).
Timepoint [1] 0 0
28 days after the first injection of [225Ac]Ac-FL-020
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
From ICF signature and up to 42 days after the last dose of study treatment and then during the long-term follow-up period
Secondary outcome [1] 0 0
Dose escalation and dose expansion: Absorbed doses
Timepoint [1] 0 0
During one week following the injection of [111In]In-FL-020
Secondary outcome [2] 0 0
Peak Plasma Concentration (Cmax)
Timepoint [2] 0 0
During one week following the first injection of [225Ac]Ac-FL-020
Secondary outcome [3] 0 0
Area Under the Plasma concentration versus time curve
Timepoint [3] 0 0
During one week following the first injection of [225Ac]Ac-FL-020
Secondary outcome [4] 0 0
Overall response rate
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Disease Control Rate
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Best Overall response
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Progression Free Survival
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
Overall Survival
Timepoint [8] 0 0
2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Genesiscare Murdoch - Murdoch
Recruitment postcode(s) [1] 0 0
- Murdoch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Full-Life Technologies GmbH
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT06492122
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Full-Life Technologies GmbH
Address 0 0
Full-Life Technologies GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Full-Life Technologies GmbH
Address 0 0
Country 0 0
Phone 0 0
+49 6221 648 4000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06492122