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A Phase 1 Study of AMG 160 in Subjects with Metastatic Castration-resistant Prostate Cancer

Study Type/Phase: Phase 1
Status: Recruiting

The purpose of this study is to evaluate the safety, effectiveness and dosing of an investigational drug called AMG 160 in patients with metastatic castration-resistant prostate cancer. AMG 160 is a type of protein being used to stimulate the body's immune system to kill cancer cells. This is a Phase 1 trial that will consist of 6 parts, but patients at El Camino Hospital will only participate in Part 5. During Part 5, AMG 160 will be administered in the El Camino Hospital outpatient infusion center. Patients will be monitored for 6 to 8 hours after the start of each AMG 160 dose in the first month. AMG 160 has not been approved for use by the U.S. Food and Drug Administration (FDA). This study includes a screening period, a treatment period lasting approximately 6 months, and a follow-up period of up to 3 years from the first dose of AMG 160.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • ≥ 18 years of age
  • Subjects with histologically or cytologically confirmed metastatic castration-resistant prostate cancer who are refractory to a novel antiandrogen therapy and have failed at least 1 (but not more than 2) taxane regimens
  • Has undergone bilateral orchiectomy or on continuous androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist
  • Total serum testosterone ≤ 50 ng/dL or 1.7 nmol/L
  • Evidence of progressive disease (1 or more Prostate Cancer Working Group 3 criteria)
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0–1
  • Prior prostate-specific membrane antigen targeted therapy
  • Anticancer therapy or immunotherapy within 4 weeks of start of first dose Needing chronic systemic corticosteroid therapy or other immunosuppressive therapies
  • Active autoimmune disease or any other diseases requiring immunosuppressive therapy during study
  • Has central nervous system metastases, leptomeningeal disease, or spinal cord compression
  • Myocardial infarction, unstable angina, cardiac arrhythmia requiring medication and/or symptomatic congestive heart failure within 12 months of the first dose of AMG 160

Principal Investigator

Shane Dormady, MD

Sponsor

Amgen Inc.

NCT Number

NCT03792841

Contact

Kathy Miller, Clinical Research Coordinator
Taft Center for Clinical Research
650-962-4562
kathryn_miller@elcaminohealth.org

Mandy Kaur, Clinical Research Intern
Taft Center for Clinical Research
650-691-4820
mandy_kaur@elcaminohealth.org

 

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