A Phase 1, First-in-human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Condition: Hormone-refractory Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT05997615
Sponsor: Amunix, a Sanofi Company
Phase: Phase 1/Phase 2
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
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.
View trial on ClinicalTrials.gov