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RecruitingLast updated: 9 November 2023

This study is evaluating how safe and effective a new drug (called AMX-500) is in people with metastatic castration-resistant prostate cancer (mCRPC)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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Clinical summary

Summary

This study will be conducted in four parts and will commence with dose escalation of the study drug (called AMX-500) as a monotherapy (Part 1), followed by monotherapy dose expansion (Part 2).

AMX-500 will be administered via intravenous (IV) infusion.

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). 

Conditions

This trial is treating patients with metastatic castration-resistant prostate cancer

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Amunix, a Sanofi Company

Scientific Title

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)

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