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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)

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

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

I/II

More information

Trial Identifiers

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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)

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.

Exclusion

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

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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