for males ages 18 years and up (full criteria)
study started
estimated completion



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


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.


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


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


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


accepting new patients
Start Date
Completion Date
AmgenTrials clinical trials website
Phase 1
Study Type
Last Updated