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

PHASE1RECRUITING

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).

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

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) or 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.

Adequate organ function as defined by: Absolute neutrophil count (ANC) ≥2 x 10^9/L (2000/µL), Hemoglobin ≥10.0 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), ALP ≤2.5 x ULN (ALP ≤5.0 x ULN, if liver or bone 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

Exclusion criteria

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.

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.

Radium-223 within 6 months prior to the first study treatment administration.

[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.

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.

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.

Known history of myelodysplastic syndrome.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: Male

Things to know

Study dates

Study start: 2024-10-01

Primary completion: 2025-09-01

Study completion finish: 2026-12-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06492122

Intervention or treatment

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

Conditions

• Metastatic Castration-resistant Prostate Cancer

Image related to Metastatic Castration-resistant Prostate Cancer

Condition: Metastatic Castration-resistant Prostate Cancer
DRUG: [225Ac]Ac-FL-020 and other drugs
Murdoch, Not Specified, Australia
Sponsor: Full-Life Technologies GmbH

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

Genesiscare Murdoch

Research sites nearby

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Genesiscare Murdoch
Murdoch, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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.	DRUG: [225Ac]Ac-FL-020 \[225Ac\]Ac-FL-020 injected intravenously

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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.	Not Specified	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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Dose escalation and dose expansion: Absorbed doses	Absorbed doses in different organs and tumors	During one week following the injection of [111In]In-FL-020
Peak Plasma Concentration (Cmax)	Pharmacokinetics	During one week following the first injection of [225Ac]Ac-FL-020
Area Under the Plasma concentration versus time curve	Pharmacokinetics	During one week following the first injection of [225Ac]Ac-FL-020
Overall response rate	Anti-tumor activity via imaging assessments and PSA levels	2 years
Disease Control Rate	Anti-tumor activity via imaging assessments and PSA levels	2 years
Best Overall response	Anti-tumor activity via imaging assessments and PSA levels	2 years
Progression Free Survival	Anti-tumor activity via imaging assessments and PSA levels	2 years
Overall Survival	Anti-tumor activity	2 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: Study With [225Ac]Ac-FL-020 in mCRPC Participants