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Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07214961•ARTBIO Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Male participants at least 18 years of age
•ECOG PS of 0 to 2
•Progressive mCRPC
•Previous treatment with at least one novel ARPI
•Prior orchiectomy and/or prior or ongoing androgen-deprivation therapy
•Prior treatment with at least one taxane regimen or patient refusing or considered appropriate by treating physician to delay taxane therapy
•177Lu-PSMA experienced Group only: Prior treatment with at least one dose of 177Lu-PSMA
•At least one PSMA-avid distant metastatic lesion
•Adequate bone marrow, renal, and hepatic function

Exclusion Criteria

•Blockage in the bladder or kidneys
•Untreated or uncontrolled brain metastases. Treated brain metastases are permitted provided they are neurologically stable
•Symptomatic, or clinical or radiologic findings indicative of impending cord compression.
•History of myelodysplastic syndrome (MDS), treatment-related acute myeloid leukaemia or features suggestive of MDS/acute myeloid leukaemia.
•A known additional malignancy that has required active treatment within the past two years before start of study treatment, except for adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ that has undergone curative therapy

Locations (3)

BAMF Health

Grand Rapids, Michigan, United States

XCancer

Omaha, Nebraska, United States

United Theranostics

Princeton, New Jersey, United States

Key Dates

Start Date

November 3, 2025

Primary Completion Date

November 3, 2027

Completion Date

November 3, 2028

Last Updated

February 4, 2026

Enrollment

ESTIMATED participants

Conditions

Prostate Cancer (CRPC)Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Interventions

AB001

DRUG

Contacts

Snr Director, Clinical Operations

CONTACT

+16178525700 trials@artbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity

Imaging of Solid Tumors Using DLL3 SPECT

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