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

Investigating an Investigational Medication for Prostate Cancer

Recruiting
18 years or above
Male
Phase 1/2
215 participants needed
2 Locations

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
  • Age: 18 years or above
  • 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 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.

Updated on 03 Dec 2024. Study ID: NCT05997615

This study investigates an investigational medication for prostate cancer. Prostate cancer is a disease where cancer cells form in the tissues of the prostate, a gland in the male reproductive system. The purpose of this study is to explore how different doses of the investigational medication work when given alone and in combination with other treatments.

Participants will receive the investigational medication in different stages. The first stage involves increasing doses of the medication given alone, followed by an expansion stage where the same medication is given at a fixed dose. Later stages may involve combining the investigational medication with other treatments to see how they work together.

  • Who can participate: Adults with confirmed prostate cancer, including metastatic disease (spread of cancer to other parts of the body), who have already received at least one prior taxane regimen and have an ECOG performance status (a scale to assess how a patient's disease is progressing) of 0 to 2 may participate.
  • Study details: Participants will receive the investigational medication either alone or in combination with other treatments. The study will assess different doses to find the most effective and safe treatment plan.
  • Study timelines: The study will last up to 48 months.

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