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

Hormone-refractory Prostate Cancer Clinical Trial

Official 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)

Clinical Trial Summary

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).

Clinical Trial Description

Duration of the study up to approximately 48 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05997615
Study type Interventional
Source Sanofi
Contact Trial Transparency email recommended (Toll free for US & Canada)
Phone 800-633-1610
Email contact-us@sanofi.com
Status Recruiting
Phase Phase 1/Phase 2
Start date August 10, 2023
Completion date September 29, 2027
View Details
See also
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