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A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination with Androgen Receptor Pathway Inhibitors in Participants with Metastatic Hormone-sensitive Prostate Cancer
Status: Recruiting
The main goal of this study is to see if it's safe for people to take xaluritamig together with either darolutamide or abiraterone.
Sex: Male
Age Group: 18 years and over
Inclusion Criteria:
• diagnosis of metastatic adenocarcinoma of the prostate
• started androgen deprivation therapy (ADT) (luteinising hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomy) with or without androgen receptor pathway inhibitor (ARPI) (pre-enrollment treatment with enzalutamide, abiraterone, apalutamide, or darolutamide are allowed).
• first treatment with ADT should be no longer than 12 weeks before starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:
• history of central nervous system (CNS) metastases
• autoimmune disease requiring systemic treatment in the past 2 years
• prior radiotherapy (to the prostate and/or to all visible metastatic lesions; palliative radiation within 2 weeks prior to first dose of study treatment is allowed
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions:
Cancer
Keywords:
Clinics and Surgery Center (CSC), Metastatic Hormone-sensitive Prostate Cancer, mHSPC, prostate cancer
Study Contact: Nicholas Zorko - zorko004@umn.edu
Principal Investigator: Nicholas Zorko
Phase: PHASE1
IRB Number: STUDY00025859
See this study on ClinicalTrials.gov