A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer

• Status: Recruiting
• Trial end date: 2025-09-12
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate the safety and tolerability of AMG 757 and will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

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 ≤ 1

• Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757

• 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 DLL3-targeted therapy may be eligible if discussed with Amgen medical monitor prior to enrollment