A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer
NCT ID: NCT04702737
Last Updated: 2025-09-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2021-06-10
2024-07-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Exploration
The maximum tolerated dose (MTD) will be estimated using isotonic regression (Ji et al, 2010). The recommended phase 2 dose (RP2D) may be identified based on emerging safety data prior to reaching an MTD.
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Part 2: Dose Expansion
Participants will receive the RP2D/MTD identified in Part 1 (dose exploration) of the study.
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Interventions
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Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men aged ≥ 18 years at time of signing the informed consent.
* Metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC) defined by histology, immunohistochemistry, or genomic analyses of baseline tumor tissue (by local assessment) or circulating tumor DNA (ctDNA) (by local assessment) as per protocol
* At least 1 line of prior systemic treatment per protocol.
* Participants with treatment-emergent NEPC or de novo NEPC with histologic evidence of prostate cancer with neuroendocrine differentiation without a history of bilateral orchiectomy are required to remain on luteinizing hormone-releasing hormone (LHRH) analogue therapy during the course of protocol therapy
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Prostate Cancer Working Group 3 (PCWG3) modifications
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
* Participants with treated brain metastases are eligible provided they meet defined criteria
* Adequate organ function as defined in protocol
Exclusion Criteria
* Malignancy treated with curative intent and with no known active disease present for ≥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
* Adequately treated non-muscle invasive urothelial carcinoma
* History or presence of hematological malignancies unless curatively treated with no evidence of disease ≥ 2 years
* Untreated or symptomatic brain metastases and leptomeningeal disease
* Anti-tumor therapy within 28 days of study day 1; concurrent use of hormone deprivation therapy for hormone refractory prostate cancer is permitted; participants on a stable bisphosphonate or denosumab prior to study day 1 are eligible
Exceptions:
* Participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicities have resolved to Grade ≤ 1
* Prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
* Participants who received androgen signaling inhibitor are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade ≤ 1
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior study day 1
* Active autoimmune disease requiring systemic treatment within the past 2 years
* Known positive test for human immunodeficiency virus (HIV) or hepatitis
* Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade 0 or 1 (with the exception of alopecia or toxicities that are stable and well-controlled)
* History of hypophysitis or pituitary dysfunction
* Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Participants on prior delta-like ligand 3 (DLL3)-targeted therapy may be eligible if discussed with Amgen Medical Monitor prior to enrollment
* Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-COV2) infection unless agreed upon with Medical Monitor and with no acute symptoms of coronavirus disease 2019 (COVID19) disease within 14 days prior to first dose of investigational product (counted from day of positive test for asymptomatic participants).
18 Years
MALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
University of California at San Francisco Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Community Health Network MD Anderson Cancer Center - North
Indianapolis, Indiana, United States
Washington University
St Louis, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Medizinische Universitaet Graz
Graz, , Austria
Ordensklinikum Linz Elisabethinen
Linz, , Austria
Landeskrankenhaus Salzburg
Salzburg, , Austria
Universitair Ziekenhuis Gent
Ghent, , Belgium
Gustave Roussy
Villejuif, , France
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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References
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Aggarwal R, Rottey S, Bernard-Tessier A, Mellado B, Kosaka T, Stadler WM, Horvath L, Greil R, O'Neil B, Siddiqui BA, Bauernhofer T, Bilen MA, Eskens F, Sandhu S, Shaw C, Ju CH, Decato BE, Yu B, Aparicio A. Safety and Efficacy of Tarlatamab in Patients with Neuroendocrine Prostate Cancer: Results from the Phase 1b DeLLpro-300 Study. Clin Cancer Res. 2025 Sep 15;31(18):3854-3863. doi: 10.1158/1078-0432.CCR-25-1211.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20200040
Identifier Type: -
Identifier Source: org_study_id
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