A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
Stopped early · Phase 1
Conditions studied: Metastatic Castration-resistant Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT04740034
- Run by
- Amgen
- People needed
- 42
- Starts
- 2021-04-29
- Expected to finish
- 2024-06-24
- Last updated by the study team
- 2025-06-17
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- UCSF — San Francisco, California, United States
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
- Florida Cancer Specialists — Sarasota, Florida, United States
- Tulane Cancer Center — New Orleans, Louisiana, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Thomas Jefferson University - Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States
- Tennessee Oncology — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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