RecruitingPhase 1Phase 2NCT07117760

Prospective Clinical Trial of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer

Prospective Clinical Trial of Low-dose 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer


Sponsor

First Affiliated Hospital of Fujian Medical University

Enrollment

20 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

PSMA is an ideal target for precision diagnosis and treatment of prostate cancer. LNC1011 is a novel albumin-binding PSMA-targeted radioligand. This study aims to explore the safety and efficacy of 225Ac-labeled LNC1011 for treating patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new radioactive drug called 225Ac-LNC1011 in men with advanced prostate cancer that has spread and no longer responds to hormone therapy (called metastatic castration-resistant prostate cancer, or mCRPC). The drug targets a protein called PSMA found on prostate cancer cells and delivers radiation directly to the tumor. **You may be eligible if...** - You have mCRPC — prostate cancer that has spread despite having very low testosterone levels - Your PSA level has risen at least twice, or your cancer has shown new lesions on imaging - You have received prior hormone therapy (like enzalutamide or abiraterone) and at least one chemotherapy (taxane-based) - Your PSMA PET scan shows positive uptake on cancer lesions - You are in reasonably good physical condition (ECOG 0–2) **You may NOT be eligible if...** - Your cancer does not show PSMA expression on a PET scan - You have active serious infections or significant organ dysfunction - You have had prior PSMA-targeted radioligand therapy - You have brain metastases - Your bone marrow function is insufficient Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG225Ac-LNC1011

administered intravenously once every 8-10 weeks (1 cycle) for 4 cycles

DRUG68Ga-PSMA-11

Intravenous dose of approx. 150 MBq at screening and at time of centrally confirmed radiographic progressive disease


Locations(1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

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NCT07117760


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