Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Study of Investigational Medication in 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 an investigational medication for metastatic castration resistant prostate cancer (mCRPC). The purpose of this study is to understand the safety, how the body processes the investigational medication, and its preliminary effectiveness in treating mCRPC.
Participants in the study will receive the investigational medication in different parts. Initially, there will be a dose escalation phase to find the appropriate dose, followed by an expansion phase to further evaluate the medication. Later parts of the study may involve combining the investigational medication with other treatments to assess the effects of combination therapy.
- Who can participate: Men with metastatic castration resistant prostate cancer who have been previously treated with at least one taxane regimen and have a life expectancy of more than 6 months may be eligible. Participants must have an ECOG performance status of 0 to 1 and have documented progressive disease.
- Study details: Participants will receive the investigational medication in phases, starting with a dose escalation to find the correct dose, followed by a dose expansion. The study may also explore combination therapy in later stages.
- Study timelines: The study will last up to approximately 48 months.
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