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

NCT06492122 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-29

No results posted yet for this study

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

Interventions

DRUG

[225Ac]Ac-FL-020

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

DRUG

Blood samples for PK

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

DRUG

[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

PROCEDURE

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

PROCEDURE

SPECT/CT images

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

Sponsors & Collaborators

  • Full-Life Technologies GmbH

    lead INDUSTRY

Principal Investigators

  • Full-Life Technologies GmbH · Full-Life Technologies GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06492122 on ClinicalTrials.gov