Summary

Eligibility
for males ages 18-65 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Keywords

Neuroendocrine Prostate Cancer De novo or treatment emergent neuroendocrine prostate cancer Delta-like protein 3 (DLL3) Non-canonical Notch ligand Prostatic Neoplasms AMG 757

Eligibility

You can join if…

Open to males ages 18-65

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California at San Francisco Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT04702737
Phase
Phase 1
Study Type
Interventional
Last Updated