Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Study of Investigational Medication for 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 prostate cancer, a disease where cancer cells form in the tissues of the prostate. The purpose of this study is to understand how the investigational medication works as a single agent and in combination with other treatments. The study will be conducted in four parts: starting with dose escalation as a monotherapy and then expanding to combination therapies.
Participants will undergo a series of procedures to monitor their health and the effects of the investigational medication. This includes imaging tests like CT, MRI, or bone scans to track the presence of metastatic lesions, which are cancer cells that have spread to other parts of the body. The study will not include any timeline or visit information in this section.
- Who can participate: Men with prostate adenocarcinoma or metastatic prostate cancer can participate if they have at least one metastatic lesion and have been treated with one or more prior taxane regimens. Participants must have an ECOG performance status of 0 to 1 and a life expectancy of more than 6 months.
- Study details: Participants will be involved in different study parts, starting with receiving the investigational medication as a single agent and potentially moving to combination therapy. Participants will be monitored for safety and response to the treatment.
- Study Timelines: The study will last up to 48 months.
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