A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
Age: 18 years - 66+
Healthy Subjects: No
Study Phase: Phase 1
Recruitment Status: Recruiting
Start Date: April 29, 2021
End Date: September 30, 2024
- 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.
- HIV, HBV, and/or 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. eGFR ≥ 30 mL/min, AST/ALT ≤ 3 x ULN, Hgb ≥ 9 g/dL, Plt ≥ 100,000 / mm3, ANC ≥ 1500 / mm3).
- Subject has been diagnosed with or treated for another malignancy 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.
- Prostatic Neoplasms