A Study of Tarlatamab (AMG 757) in Participants With Neuroendocrine Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Jan 4, 2026
  • participants needed
    60
  • sponsor
    Amgen
Updated on 12 May 2022

Summary

To evaluate the safety and tolerability of Tarlatamab and will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

Details
Condition Neuroendocrine Prostate Cancer
Treatment AMG 757, Tarlatamab
Clinical Study IdentifierNCT04702737
SponsorAmgen
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant has provided informed consent prior to initiation of any study specific activities/procedures
Men aged ≥ 18 years at time of signing the informed consent
Metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC) defined by histological, 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
For participants with treatment-emergent NEPC or de novo NEPC with histologic evidence of prostate cancer with neuroendocrine differentiation
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

History of other malignancy within the past 2 years, with exceptions
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 is permitted; participants on a stable bisphosphonate or denosumab for ≥ 30 days 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 ≤
Prior palliative radiotherapy must have been completed at least 7 days before the first dose of Tarlatamab
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
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
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 DLL3-targeted therapy may be eligible if discussed with Amgen medical monitor prior to enrollment
History or evidence of SARS-COV2 infection unless agreed upon with Medical Monitor and with no acute symptoms of COVID19 disease within 14 days prior to first dose of IP (counted from day of positive test for asymptomatic subjects)
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