Status:
TERMINATED
A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
Lead Sponsor:
Amgen
Conditions:
Metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with metastatic castrat...
Eligibility Criteria
Inclusion
- Pathologically confirmed prostatic adenocarcinoma.
- History of metastatic disease.
- Chemically or surgically castrate.
- Subject has received at least 2 lines of systemic therapy approved for mCRPC, with disease progression on the most recent systemic therapy as defined in Prostate Cancer Working Group 3 (PCWG3) recommendations.
- Human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV)-infected subjects that have been cured or who are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
- Subject must have adequate heart, liver, bone marrow and kidney function (e.g. estimated glomerular filtration rate \[eGFR\] ≥ 50 mL/min, aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\] ≤ 3 x upper limit of normal \[ULN\], hemoglobin \[Hgb\] ≥ 9 g/dL (without blood transfusion within 7 days from screening assessment), platelets ≥ 100,000 / mm\^3 (without platelet transfusion within 7 days from screening assessment), absolute neutrophil count \[ANC\] ≥ 1500 / mm\^3).
Exclusion
- Subject has been diagnosed with or treated for another malignancy within the past 2 years whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
- History of neuroendocrine differentiation in the subject's disease.
- Subject has a history of central nervous system (CNS) involvement by their mCRPC. Metastases stemming from bone are allowed.
- Subject has clinically significant CNS pathology.
- Subject requires chronic immunosuppressive therapy.
- Subject has a history of major cardiac abnormalities.
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04740034
Start Date
April 29 2021
End Date
June 24 2024
Last Update
June 17 2025
Active Locations (7)
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1
UCSF
San Francisco, California, United States, 94158
2
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
3
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
4
Tulane Cancer Center
New Orleans, Louisiana, United States, 70112