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

Completed

• Conditions: Prostate Cancer; neuro-endocriene prostaatkanker; Neuroendocrine Prostate Cancer; 10036958

• Registration Number: NL-OMON51934
• Lead Sponsor: Amgen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3

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
<= 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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Treatment-emergent adverse events, treatment-related adverse events, and<br /><br>changes in vital signs, electrocardiogram (ECG), and<br /><br>clinical laboratory tests<br /><br>2. Dose limiting toxicities (DLTs)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. o Objective response (OR) per Response Evaluation Criteria in Solid Tumors<br /><br>(RECIST) 1.1<br /><br>o Duration of response (DOR) per RECIST 1.1<br /><br>o Radiographic Progression-free survival (PFS) per Prostate Cancer Working<br /><br>Group 3 (PCWG3)<br /><br>o Overall survival (OS)<br /><br>o Disease Control Rate (DCR) per RECIST 1.1<br /><br>2. PK parameters for tarlatamab following intravenous (IV) administration<br /><br>including, but not limited to, maximum serum concentration (Cmax), minimum<br /><br>serum concentration (Cmin), area under the concentration-time curve (AUC) over<br /><br>the dosing interval, accumulation ratio, and half-life (t1/2)</p><br>