Lay Title: A Study Evaluating the Safety of a new drug (ARV-110) in Patients with Metastatic Castration-Resistant Prostate Cancer
Technical Title: A Phase 1/2, open-label, dose-escalation and cohort expansion clinical trial of ARV-110 in patients with metastatic castration resistant prostate cancer
Disease Type: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Basic information: The purpose of this study is to evaluate the safety of a new drug, ARV-110. ARV-110 is a potent, selective, orally bioavailable, Proteolysis-Targeting Chimera (PROTAC®) small molecule that induces the degradation of the androgen receptor (AR). ARV-110 is being developed for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC). The study drug must be taken with food and participants will be instructed to apply sunscreen products and avoid excessive sun exposure while on treatment.
Research Procedures (not a complete list): During screening, you will have an electrocardiogram, CT scan, Bone scan and lab work. Based on your scans, you may need to have a biopsy. Once you begin treatment, you will need to come to clinic approximately every 4 weeks for the duration of your participation in the study. You will also need to return for scans every 8 weeks for the duration of the study.
Eligibility Criteria (not a complete list):
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ClinicalTrials.gov Identifier: NCT03888612