Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

A study to evaluate the safety and tolerability of AMG 160 and in combination with pembrolizumab in adult subjects with metastatic castration-resistant prostate cancer (mCRPC), and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

Official Title

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen Half-life Extended Bispecific T-cell Engager AMG 160 in Subjects With Metastatic Castration-resistant Prostate Cancer

Details

This is a phase I, first-in-human study to evaluate the safety and tolerability of AMG 160; a half-life extended (HLE) bispecific T-cell engager (BiTE®) antibody construct, alone and in combination with pembrolizumab in subjects with metastatic castration-resistant prostate cancer.

Keywords

Metastatic Castration-resistant Prostate Cancer Prostate Cancer AMG 160 HLE-BiTE® mCRPC PSMA BiTE® Bispecific T-Cell engager Immunotherapy Immuno-oncology Immunooncology Solid tumor PSMA Targeted Therapy Prostatic Neoplasms Etanercept Pembrolizumab Outpatient Oncology Center AMG 160 + Pembrolizumab AMG 160 + Etanercept Prophylaxis

Eligibility

For males ages 18 years and up

All Parts

Inclusion Criteria:

  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures
  • Subjects with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (abiraterone, enzalutamide, and/or apalutamide) and have failed at least 1 (but not more than 2) taxane regimens (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Progression on novel antiandrogen therapy may have occurred in the non-metastatic CRPC setting
  • Subject should have undergone bilateral orchiectomy or should be on continuous androgen-deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist or antagonist
  • Total serum testosterone </= 50 ng/dL or 1.7 nmol/L
  • Evidence of progressive disease, defined as 1 or more PCWG3 criteria: PSA level >/=1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart, nodal or visceral progression as defined by RECIST 1.1 with PCGW3 modifications, and/or appearance of 2 or more new lesions in bone scan

Exclusion Criteria:

  • Any anticancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone agonist (LHRH)/GnRH analogue (agonist/antagonist). Subjects on a stable bisophosphonate or denosumab regimen for >/= 30 days prior to randomization are eligible
  • Prior PSMA-targeted therapy (subjects on prior therapy may be eligible if discussed with Amgen medical monitor prior to enrollment)
  • Central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
  • Active autoimmune disease or any other diseases requiring immunosuppressive therapy while on study
  • Needing chronic systemic corticosteroid therapy (prednisone > 10 mg per day or equivalent) or any other immunosuppressive therapies (including anti-tumor necrosis factor alpha [TNF alpha] therapies) unless stopped 7 days prior to start of first dose
  • Myocardial infarction, unstable angina, cardiac arrhythmia requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 160

Part 2 only:

  • Subjects on a prior PD-1 or PD-L1 inhibitor who experienced a Grade 3 or higher immune-related adverse event prior to first day of dosing
  • History or evidence of interstitial lung disease or active, non-infectious pneumonitis

Part 3 only:

-Evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product

Locations

  • Research Site accepting new patients
    Los Angeles California 90095 United States
  • Research Site accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT03792841
Phase
Phase 1
Study Type
Interventional
Last Updated