ARX517 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Active:	Yes
Cancer Type:	Prostate Cancer Unknown Primary	NCT ID:	NCT04662580
Trial Phases:	Phase I	Protocol IDs:	ARX517-2011 (primary) NCI-2021-03637
Eligibility:	18 Years and older, Male	Study Type:	Treatment
Study Sponsor:	Ambrx, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04662580

Summary

This is a phase 1 study to assess the safety and tolerability of ARX517 in adult subjects
with Metastatic Castration-Resistant Prostate Cancer (mCRPC).

Objectives

This is a first-in-human, Phase 1, multicenter, open-label study to evaluate the safety,
PK, PDy, and preliminary anti-tumor activity of ARX517 in adult subjects with mCRPC with
serum testosterone level < 50 ng/dL at screening who are resistant or refractory to
standard therapies. Phase 1a (dose-escalation) and Phase 1b (dose-expansion) stages will
identify the MTD and/or RDDs.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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