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

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

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

Inclusion Criteria9

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
Lu-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 Criteria5

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