Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer

Inclusion Criteria

• Inclusion Criteria: Applicable to Parts 1 and 2 - Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging - Have documented progressive mCRPC based on ≥ 1 of the criteria (per PCWG3) - Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including abiraterone, apalutamide, darolutamide, and/or enzalutamide - Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel) - Are deemed unsuitable for standard of care Applicable to Part 2 Cohort 1 • Must have received standard-of-care radioligand-based therapies, including PSMA-targeted radiopharmaceutical therapy, such as 177Lu-PSMA-617 Applicable to Part 3a and Part 4a - Have metastatic CRPC, defined by ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging that has documented progressive disease (PD) based on ≥ 1 of the following criteria (per PCWG3) - Have metastatic HSPC, defined by at least 1 and no more than 5 metastatic lesions with no visceral involvement that are present on baseline CT, MRI, or bone scan imaging - Have biochemical recurrent prostate cancer Exclusion Criteria: - Presence of dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell components - Has acute or chronic infections - Has a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5500, per the Investigator - Has lesions in proximity of vital organs - Has known active CNS metastases and/or carcinomatous meningitis The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.