Prostate Cancer Clinical Trial
ARX517 in Subjects With Metastatic Castration-resistant Prostate Cancer
Summary
A Phase 1, Multicenter, Open-label, Dose-escalation, and Dose expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of ARX517 in Subjects with Advanced Solid Tumor with known PSMA Who Failed Prior Standard Therapies
Full Description
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 in subjects with mCRPC who are resistant or refractory to standard therapies. Phase 1a and 1b dose-escalation and dose expansion stages will identify the MTD and/or RP2D(s). Phase 2 will randomize subjects to receive ARX517 at the RP2D(s) 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 Criteria
Key Inclusion Criteria:
Male subjects ≥ 18 years at the first time of providing written informed consent.
Histologically confirmed prostate adenocarcinoma.
Documented metastatic disease.
Castration-resistant prostate cancer per the Prostate Cancer Working Group 3 (PCWG3).
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 treatment with at least two FDA-approved therapies for metastatic prostate cancer with at least one being an androgen receptor signaling inhibitor
Adequate blood counts
Key Exclusion Criteria:
Have central nervous system (CNS) metastasis, unless the CNS metastasis was treated with local therapy and has proven to be stable over the last 2 months prior to the enrollment date, and not currently requiring ongoing systemic steroid treatment
History of any invasive malignancy (other than primary) within previous 2 years prior to the enrollment date that requires active therapy
Marked baseline prolongation of QT/QT interval corrected for heart rate (QTc), e.g., a triplicate average QTc interval > 480 milliseconds (CTCAE Grade 1) using Fridericia's QT correction formula.
Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease within 12 months prior to enrollment date
Clinically significant ocular findings by a qualified ophthalmologist or optometrist including active ocular infections or chronic corneal disorders
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There are 9 Locations for this study
Los Angeles California, 90095, United States
San Francisco California, 94143, United States
Atlanta Georgia, 30322, United States
Indianapolis Indiana, 46202, United States
Ann Arbor Michigan, 48109, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68130, United States
New York New York, 10065, United States
Seattle Washington, 98195, United States
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