NCT 05997615
Brief Summary
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).
Intervention / Treatment
- Drug: AMX-500 (SAR446329)
Inclusion Criteria:
- Has histological, pathological, and/or cytological confirmation of prostate adenocarcinomacancer arising from mucus-producing glands in organs OR metastatic disease typical of prostate cancer (ie, involving bone or pelvic lymph nodessmall bean-shaped structures that filters harmful substances from lymph fluid or para-aortic lymph nodes)
- Has metastatic disease, defined by ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scana type of medical imaging that uses a radioactive tracer to detect bone conditions or abnormalities 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.