Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Study on Investigational Medication for Metastatic Castration Resistant Prostate Cancer
Study Overview
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).
Study Details
Duration of the study up to approximately 48 months.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Hormone-refractory Prostate Cancer
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Age: 18 years or above
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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.
This study investigates the effects of an investigational medication on metastatic castration-resistant prostate cancer (mCRPC). The purpose is to explore how the medication works in the body and its safety for individuals with this type of cancer.
The study will focus on evaluating the safety, how the body processes the investigational medication, and its initial effectiveness for people with mCRPC.
- Who can participate: Men with confirmed prostate adenocarcinoma or metastatic disease typical of prostate cancer, who have progressive mCRPC and have been treated with at least one prior taxane regimen, may be eligible. Participants must have an ECOG performance status of 0 to 1 and a life expectancy of more than 6 months.
- Study details: Participants will receive an investigational medication to assess its effects on prostate cancer. The study will evaluate safety and how the medication is processed in the body.
- Study timelines: The study will last up to approximately 48 months.
