ARX517 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Prostate Cancer
Unknown Primary
ARX517-2011 (primary)
NCI-2021-03637
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).
Objectives
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
- Male subjects = 18 years at the first time of providing written informed consent.
- Histologically confirmed prostate adenocarcinoma.
- Documented metastatic disease and evidence of disease progression
- Castration-resistant prostate cancer defined as surgical or medical castration with serum testosterone levels of = 50 ng/dL (1.73 nM) at Screening. For patients who have not undergone an orchiectomy, must be undergoing treatment with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist and must agree to continue such therapy while on study treatment.
- Prior receipt of the following for metastatic prostate cancer:
- at least two lines of treatment
- at least two Food and Drug Administration (FDA)-approved therapies with at least one being a second-generation androgen receptor signaling inhibitor (e.g., abiraterone, darolutamide, apalutamide, or enzalutamide).
- Adequate blood counts Key
Treatment Sites in Georgia
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