A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
Megadott ok: Sponsor strategic decision
Key facts
- Where
- Denver, Nashville, New Orleans, New York, Philadelphia, San Francisco és Sarasota, Egyesült ÁllamokSee the 7 sites
- Phase
- 1. fázis
Where in Egyesült Államok
- Sarah Cannon Research Institute at HealthONEDenver, Egyesült ÁllamokNo longer taking part
- Tennessee OncologyNashville, Egyesült ÁllamokNo longer taking part
- Tulane Cancer CenterNew Orleans, Egyesült ÁllamokNo longer taking part
- Icahn School of Medicine at Mount SinaiNew York, Egyesült ÁllamokNo longer taking part
- Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphia, Egyesült ÁllamokNo longer taking part
- UCSFSan Francisco, Egyesült ÁllamokNo longer taking part
- Florida Cancer SpecialistsSarasota, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Amgen
- Trial code
- NCT04740034
- Record updated
- 2025. június 17.
- Original description
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.Read full original descriptionShow less
A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of AMG 340, a Bispecific Antibody Targeting PSMA in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
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.
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 requires chronic immunosuppressive therapy; 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 a history of major cardiac abnormalities; Subject has clinically significant CNS pathology.