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

Status
Active
Cancer Type
Neuroendocrine Tumor
Prostate Cancer
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male
Study Type
Treatment
NCT ID
NCT04702737
Protocol IDs
20200040 (primary)
NCI-2021-08862
Study Sponsor
Amgen, Inc.

Summary

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

Eligibility

  1. Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  2. Men aged = 18 years at time of signing the informed consent.
  3. 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
  4. At least 1 line of prior systemic treatment per protocol.
  5. For participants with treatment-emergent NEPC or de novo NEPC with histologic evidence of prostate cancer with neuroendocrine differentiation.
  6. 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
  7. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Prostate Cancer Working Group 3 (PCWG3) modifications
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status of = 2
  9. Participants with treated brain metastases are eligible provided they meet defined criteria
  10. Adequate organ function as defined in protocol
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