Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)

The study will be conducted in 4 parts and will commence with dose escalation of AMX-500 as a monotherapy (Part 1), followed by monotherapy dose expansion (Part 2).

• Part 1 (Monotherapy Dose Escalation): Single-agent AMX-500 dose escalation
• Part 2 (Monotherapy Dose Expansion): Single-agent AMX-500 dose expansion

The study may subsequently continue via a protocol amendment with dose escalation of AMX-500 combinations (Part 3) followed by combination therapy dose expansion (Part 4).

Duration of the study up to approximately 48 months.

Inclusion Criteria:

• Has histological, pathological, and/or cytological confirmation of prostate adenocarcinoma OR metastatic disease typical of prostate cancer (ie, involving bone or pelvic lymph nodes or para-aortic lymph nodes)
• Has metastatic disease, defined by ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging - Has documented progressive mCRPC
• Have been treated with ≥ 1 prior taxane regimens (eg, docetaxel, cabazitaxel)
• Participants deemed unsuitable for standard of care
• Has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
• Has a life expectancy more than 6 months

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 AMX 500, 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.