Prostate Cancer Clinical Trial
A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
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 castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines of therapy. The study consists of 2 parts, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Once the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability and pharmacokinetic (PK) profile of the MTD/RP2D dose of AMG 340 monotherapy in subjects with mCRPC.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
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There are 7 Locations for this study
San Francisco California, 94158, United States
Denver Colorado, 80218, United States
Sarasota Florida, 34232, United States
New Orleans Louisiana, 70112, United States
New York New York, 10128, United States
Philadelphia Pennsylvania, 19107, United States
Nashville Tennessee, 37203, United States
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