Overview

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

Status:
Recruiting
Trial end date:
2027-09-29
Target enrollment:
0
Participant gender:
Male
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amunix, a Sanofi Company
Criteria
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 2

- 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.