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