Status:
COMPLETED
Study of ES414 in Metastatic Castration-Resistant Prostate Cancer
Lead Sponsor:
Aptevo Therapeutics
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE1
Brief Summary
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. Secon...
Detailed Description
Stage 1 - Dose Escalation: The dose escalation stage of the study will test weekly doses of 0.2 mcg/kg to 300 mcg/kg over 9 dose levels (cohorts). Cohorts 1 to 3 consist of single patients and Cohorts...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2019
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02262910
Start Date
January 1 2015
End Date
February 18 2019
Last Update
August 28 2019
Active Locations (7)
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1
University of California
San Francisco, California, United States, 94143
2
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
3
Central Texas Veterans Health Care System
Temple, Texas, United States, 76504
4
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109