A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Delta-like Protein 3 Half-life Extended Bispecific T-cell Engager AMG 757 in Subjects with De Novo or Treatment Emergent Neuroendocrine Prostate Cancer - 20200040

Amgen0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

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•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
•positive immunohistochemical staining for chromogranin and/or synaptophysin in
•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
•NEPC diagnosis they had no prior diagnosis or treatment for prostate carcinoma)
•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
•guidelines, have an Eastern Cooperative Oncology Group (ECOG) performance
•<= 2, and adequate organ function.
•For a full list of eligibility criteria, please refer to Section 5.1 to Section
•5.2 of the protocol.

•-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

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