ARX517 as Monotherapy and in Combination Regimens in Subjects With Metastatic Castration-resistant Prostate Cancer
Prostate Cancer
Unknown Primary
ARX517-2011 (primary)
NCI-2021-03637
Summary
This is a phase 1/2 study to assess the safety and tolerability of ARX517 as monotherapy or
in combination in adult subjects with Metastatic castration-resistant prostate cancer
(mCRPC).
Objectives
This is a first-in-human, Phase 1/2, multicenter, open-label study to evaluate the safety,
PK, PDy, and preliminary anti-tumor activity of ARX517 as monotherapy or in combination 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 RP2Ds. Phase 2 will randomize subjects
to receive ARX517 at the RP2Ds or ICT as comparator. The ICT to be used in Phase 2 will be
determined after reviewing all available clinical data in Phase 1.
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.
- Ongoing therapy with (and willing to continue with) a gonadotropin-releasing hormone agonist or antagonist (unless prior orchiectomy) AND serum testosterone level < 50 ng/dL at Screening.
- 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
Treatment Sites in Georgia
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