Spots Global Cancer Trial Database for ARX517 in Subjects With Metastatic Castration-Resistant Prostate Cancer
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Trial Identification
Brief Title: ARX517 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Official Title: A Phase 1, Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of ARX517 in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Are Resistant or Refractory to Prior Standard Therapies
Study ID: NCT04662580
Conditions
Interventions
Study Description
Brief 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).
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
University of California Los Angeles School of Medicine, Los Angeles, California, United States
UCSF, San Francisco, California, United States
The Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Urology Cancer Center, XCancer Research Network, Omaha, Nebraska, United States
Weill Cornell Medical College, New York, New York, United States
University of Washington, Seattle, Washington, United States
Contact Details
Name: Ambrx
Affiliation: Ambrx, Inc.
Role: STUDY_DIRECTOR
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