Open
Actively Recruiting
ARX517 in Subjects With Metastatic Castration-resistant Prostate Cancer
About
Brief Summary
A Phase 1/2, Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of ARX517, with Randomized Comparison to Investigator's Choice of Treatment (ICT), in Subjects with Metastatic Castration-resistant Prostate Cancer who are Resistant or Refractory to Prior Standard Therapies
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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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Study Stats
Protocol No.
21-000518
Category
Bladder Cancer
Breast Cancer
Cervical Cancer
Colorectal Cancer
Esophageal Cancer
Gallbladder Cancer
Head and Neck Cancer
Kidney Cancer
Liver Cancer
Lung Cancer
Melanoma (Skin Cancer)
Non-Melanoma Skin Cancer
Other Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Sarcoma
Stomach Cancer
Uterine/Endometrial Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica