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

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

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