Study of ES414 in Metastatic Castration-Resistant Prostate Cancer

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

The study will be conducted in 2 Stages. The primary objective of Stage 1 of the study is to identify the maximum tolerated dose (MTD) of ES414 administered intravenously to patients with mCRPC. Secondary objectives are to evaluate the tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, cytokine response, and clinical activity of ES414. The primary objective of Stage 2 of the study is to evaluate the clinical activity of ES414 in patients that have or have not received prior chemotherapy. Secondary objectives are to further characterize the safety profile, PK, PD, and immunogenicity of ES414.

Key facts

Study ID

NCT02262910

Run by

Aptevo Therapeutics

People needed

35

Starts

2015-01-01

Expected to finish

2019-02-18

Last updated by the study team

2019-08-28

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the prostate. No evidence of neuroendocrine differentiation or small cell features.
• Surgically or medically castrated, with testosterone ≤ 50 ng/dL (≤ 1.7 nmol/L).
• Progressive prostate cancer by either serum PSA levels, soft tissue or bone disease as defined by the PCWG2 criteria.
• In Stage 1, patients may or may not have received prior chemotherapy for mCRPC. In Stage 2, patients will be enrolled into two cohorts based on whether or not they have received prior chemotherapy for mCRPC. Any prior chemotherapy must have been completed ≥ 4 weeks prior to administration of ES414. Additionally, in countries where abiraterone or enzalutamide are commercially available, patients in Stage 1 and 2 must have progressed on abiraterone and/or enzalutamide prior to study entry.
• ECOG ≤ 1
• Life expectancy > 6 months per investigator
• Adequate hematologic, renal, and hepatic parameters

You may not qualify if…

• Any chemotherapy, sipuleucel-T, or investigational drug in prior 4 weeks, or abiraterone or enzalutamide in prior 2 week
• Any radiation therapy in prior 2 weeks
• Any prior therapy targeted against PSMA
• History of seizures
• History of central nervous system metastasis
• History of nephrotic syndrome
• Spot urine total protein:creatinine ratio >1,000 mg/gm
• Planned palliative procedures for alleviation of bone pain
• Active infection requiring treatment with systemic anti-infectives or major surgery in prior 4 weeks.
• Any prednisone (or equivalent corticosteroids) use within 2 weeks of study entry
• Chronic immunosuppressive therapy
• Known history of HIV, hepatitis B, or hepatitis C infection
• Evidence of severe or uncontrolled systemic diseases
• History of bleeding disorders or thromboembolic events in prior 3 months

Where it is running

• University of California — San Francisco, California, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Central Texas Veterans Health Care System — Temple, Texas, United States
• University of Washington/Seattle Cancer Care Alliance — Seattle, Washington, United States
• St. Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• Peter MacCallum Cancer Centre — East Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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