ARX517 as Monotherapy and in Combination Regimens in Subjects With Metastatic Castration-resistant Prostate Cancer

Active:	Yes
Cancer Type:	Prostate Cancer Unknown Primary	NCT ID:	NCT04662580
Trial Phases:	Phase I Phase II	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 1/2 study to assess the safety and tolerability of ARX517 as monotherapy or
in combination in adult subjects with Metastatic castration-resistant prostate cancer
(mCRPC).

Objectives

This is a first-in-human, Phase 1/2, multicenter, open-label study to evaluate the safety,
PK, PDy, and preliminary anti-tumor activity of ARX517 as monotherapy or in combination 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 RP2Ds. Phase 2 will randomize subjects
to receive ARX517 at the RP2Ds or ICT as comparator. The ICT to be used in Phase 2 will be
determined after reviewing all available clinical data in Phase 1.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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