Safety, pharmacokinetics, and preliminary efficacy of AMX-500 in mCRPC

• Research type

  Research Study

• Full title

  A Phase1, first-in-human study of the safety, pharmacokinetics, and preliminary efficacy of AMX-500 in participants with metastatic castration-resistant prostate cancer (mCRPC)

• IRAS ID

  1007808

• Contact name

  Patrick Maury

• Contact email

  patrick.maury@sanofi.com

• Sponsor organisation

  Sanofi-Aventis Recherche & Développement

• Eudract number

  2023-503495-24

• Research summary

  This multipart, Phase 1, firs in human, dose-escalation, and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of AMX-500 in participants with metastatic castration-resistant prostate cancer (mCRPC). The purpose of this research study is to test the study drug AMX-500 alone or in combination with another drug at different dose levels to find out if it is safe and effective for treating mCRPC and to understand the way the body processes and reacts to the study drug.
  Approximately 215 participants are planned for enrolment globally across Parts 1 through 4., up to 65 participants in PArt 1, approx. 90 participants in Part 2, 30 participants in Part 3, and 30 participants in part 4.
  The study will be conducted in the following 4 parts:
  • Part 1 (Monotherapy Dose Escalation): Single-agent AMX 500 dose escalation
  • Part 2 (Monotherapy Dose Expansion): Single-agent AMX 500 dose expansion
  • Part 3 (Combination Dose Escalation): AMX 500 plus another therapeutic agent dose escalation
  • Part 4 (Combination Dose Expansion): AMX 500 plus another therapeutic agent dose expansion

  The study will commence with dose escalation of AMX-500 as monotherapy (Part 1), followed by monotherapy dose expansion (Part 2), then it will continue with dose escalation of AMX-500 in combination other therapeutic agent(s) (Part 3) followed by combination-therapy dose expansion (Part 4), based on the hypothesis that therapeutic combinations have the potential to maximize the efficacy of AMX-500.

  The study will be monitored by a safety assessment committee (SAC) that will be responsible for the safe conduct of the study and for making key decisions such as those related to initiating parts of the study and dose escalations.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  23/LO/0477

• Date of REC Opinion

  9 Nov 2023

• REC opinion

  Further Information Favourable Opinion