neuro-endocriene prostaatkanker Neuroendocrine Prostate Cancer Prostate Cancer
Conditions
Interventions
Tarlatamab will be administered as a short-term IV infusion Q2W (with step
dosing) in a 28-day cycle as monotherapy
Sponsors
Amgen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: o Adult subjects (>= 18 years of age) with metastatic de novo or treatment-emergent NEPC defined as one or more of the following will be eligible to enroll: histological diagnosis of small cell NEPC, prostate carcinoma with neuroendocrine differentiation as defined by positive immunohistochemical staining for chromogranin and/or synaptophysin in the majority of the tumor sample or >= 2 alterations in Tp53, RB1, and/or PTEN by immunohistochemistry (IHC) or genomic analyses of baseline tumor tissue or circulating tumor DNA (ctDNA). o Subjects are required to have progressed on at least 1 line of prior treatment, including a platinum containing regimen for de novo NEPC (if at the time of NEPC diagnosis they had no prior diagnosis or treatment for prostate carcinoma) or an androgen signaling inhibitor (eg, abiraterone, enzalutamide, and/or apalutamide) if treatment-emergent (had a previous diagnosis of prostate carcinoma prior to NEPC diagnosis). o Subjects must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with Prostate Cancer Working Group 3 (PCWG3) guidelines, have an Eastern Cooperative Oncology Group (ECOG) performance status of
Exclusion criteria
Exclusion criteria: -History of other malignancy within the past 2 years -Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease -History or presence of relevant CNS pathology such as uncontrolled epilepsy or seizure disorder, aphasia, paresis, dementia, severe brain injuries, Parkinson*s disease, cerebellar disease, organic brain disorder, or psychosis -Myocardial infarction within 12 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or clinically significant uncontrolled cardiac arrhythmia -History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of tarlatamab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Treatment-emergent adverse events, treatment-related adverse events, and changes in vital signs, electrocardiogram (ECG), and clinical laboratory tests 2. Dose limiting toxicities (DLTs) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. o Objective response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 o Duration of response (DOR) per RECIST 1.1 o Radiographic Progression-free survival (PFS) per Prostate Cancer Working Group 3 (PCWG3) o Overall survival (OS) o Disease Control Rate (DCR) per RECIST 1.1 2. PK parameters for tarlatamab following intravenous (IV) administration including, but not limited to, maximum serum concentration (Cmax), minimum serum concentration (Cmin), area under the concentration-time curve (AUC) over the dosing interval, accumulation ratio, and half-life (t1/2) | — |
Countries
Netherlands
Outcome results
None listed