RecruitingPhase 1NCT07214961

Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biodistribution and Antitumour Activity of the Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer


Sponsor

ARTBIO Inc.

Enrollment

80 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This Phase 1 study will evaluate the safety, tolerability, and preliminary effectiveness of AB001, an alpha-emitting radioligand targeting prostate-specific membrane antigen (PSMA), in patients with advanced prostate cancer who are either 177Lu-PSMA naïve or experienced. The study includes dose escalation to identify a recommended dose and dose expansion to further assess safety and anti-tumour activity. Primary objectives are to characterize the safety profile and determine the optimal dose and schedule for future studies


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of radiation therapy called AB001 — an alpha-particle radioligand therapy that delivers targeted radiation directly to prostate cancer cells via a protein they express (PSMA) — for men with advanced prostate cancer that no longer responds to hormone therapy. **You may be eligible if...** - You are a male, age 18 or older, with progressing castration-resistant prostate cancer - You have already received at least one hormonal therapy drug (like enzalutamide or abiraterone) - You have at least one PSMA-avid metastatic lesion on a PSMA scan - You have adequate blood, kidney, and liver function - If applicable: prior lutetium-177 PSMA therapy (for one study group) **You may NOT be eligible if...** - You have untreated or active brain metastases - You have signs of spinal cord compression - You have a history of myelodysplastic syndrome or treatment-related leukemia - You have a bladder or kidney blockage - You have another active cancer requiring treatment within the past 2 years 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

DRUGAB001

Pb-212 PSMA targeted alpha radioligand therapy


Locations(3)

BAMF Health

Grand Rapids, Michigan, United States

XCancer

Omaha, Nebraska, United States

United Theranostics

Princeton, New Jersey, United States

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NCT07214961


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