Lay Title: A Study Assessing the Safety and Efficacy of ARX517 in Patients with Prostate-Specific Membrane Antigen-expressing Cancers
Technical Title: A Phase 1, Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of ARX517 in Subjects with Advanced Solid Tumors
Disease Types: Metastatic Castration-Resistant Prostate Cancer (mCRPC) – contact study team directly for details regarding other cohorts
Basic information: The purpose of this study is to evaluate the safety of a new drug, ARX517, an antibody-drug conjugate that binds prostate-specific membrane antigen, and releases a chemotherapy drug into the cancer cell. ARX517 is an intravenous (into the vein) treatment.
Research Procedures (not a complete list): During screening, you will have an electrocardiogram, echocardiogram, CT scan, Bone scan, PSMA PET scan, eye exam and lab work. Once you begin treatment, you will need to come to clinic every 3 weeks for the duration of your participation in the study. You will also need to return for scans every 9 weeks for the first 24 weeks of the study, then every 12 weeks onward.
Eligibility Criteria (not a complete list):
For More Detailed Information, contact:
ClinicalTrials.gov Identifier: NCT04662580