Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With mCRPC
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ClinicalTrials.gov Identifier: NCT03792841 |
Recruitment Status :
Recruiting
First Posted : January 3, 2019
Last Update Posted : February 16, 2021
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Castration-resistant Prostate Cancer Prostate Cancer | Drug: AMG 160 Drug: Pembrolizumab Drug: Etanercept Drug: Immunomodulating Agent | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 288 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 5, 2019 |
Estimated Primary Completion Date : | January 17, 2025 |
Estimated Study Completion Date : | January 17, 2025 |

Arm | Intervention/treatment |
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Experimental: AMG 160 Treatment
Part 1: AMG 160 is administered intravenously at different dose levels.
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Drug: AMG 160
Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer
Other Name: PSMA Targeted Therapy |
Experimental: AMG 160 + Pembrolizumab
Part 2: AMG 160 is administered intravenously at different dose levels. Pembrolizumab will be administered intravenously.
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Drug: AMG 160
Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer
Other Name: PSMA Targeted Therapy Drug: Pembrolizumab Combined with AMG 160 for investigational treatment of mCRPC
Other Name: PD-1 inhibitor |
Experimental: AMG 160 + Etanercept Prophylaxis
Part 3: AMG 160 is administered intravenously at RP2D/MTD levels. Etanercept will be administered subcutaneously in cycle 1 only.
|
Drug: AMG 160
Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer
Other Name: PSMA Targeted Therapy Drug: Etanercept Prophylaxis for AMG 160-related cytokine release syndrome.
Other Name: TNF-alpha inhibitor |
Experimental: AMG 160 24 hr monitoring
Part 4: AMG 160 is administered intravenously at RP2D/MTD with 24-hour monitoring.
|
Drug: AMG 160
Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer
Other Name: PSMA Targeted Therapy |
Experimental: AMG 160 Outpatient Cohort
Part 5: AMG 160 is administered intravenously at RP2D/MTD in an outpatient setting with 8-hour monitoring.
|
Drug: AMG 160
Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer
Other Name: PSMA Targeted Therapy |
Experimental: AMG 160 + Immunomodulating Agent
Part 6: AMG 160 is administered intravenously at RP2D/MTD levels. Immunomodulating agent will be administered orally.
|
Drug: AMG 160
Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer
Other Name: PSMA Targeted Therapy Drug: Immunomodulating Agent Prophylaxis for AMG 160-related cytokine release syndrome
Other Name: Immunomodulator |
- Number of participants with dose-limiting toxicity [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Number of participants with treatment-emergent adverse events [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Number of participants with treatment-related adverse events [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Number of participants with clinically significant changes in vital signs [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Number of participants with clinically significant changes in electrocardiogram (ECG) [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Number of participants with clinically significant changes in clinical laboratory tests [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Subject incidence of changes in pharmacokinetics - maximum serum concentration (Cmax) [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Objective response (OR) [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Prostate-specific antigen (PSA) response [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Duration of response (DOR) (radiographic and PSA) [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Change in time to progression (radiographic and PSA) [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- 1, 2 and 3-year overall survival (OS) [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Other PCWG3-recommended endpoints - time to symptomatic skeletal events [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Subject incidence of changes in pharmacokinetics - minimum serum concentration (Cmin) [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Subject incidence of changes in pharmacokinetics - area under the concentration-time curve (AUC) over the dosing interval [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Subject incidence of changes in pharmacokinetics - administration including accumulation following multiple dosing [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Subject incidence of changes in pharmacokinetics - half-life [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Other PCWG3-recommended endpoints - lactate dehydrogenase [LDH] [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Other PCWG3-recommended endpoints - hemoglobin [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Other PCWG3-recommended endpoints - neutrophil-to-lymphocyte ratio [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Other PCWG3-recommended endpoints - urine N-telopeptide [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study
- Other PCWG3-recommended endpoints alkaline phosphatase [total, bone] [ Time Frame: Up to 3 years ]Parts 1, 2, 3, 4, 5, and 6 of the study

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- Life expectancy >/=6 months
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
Part 6 only:
Subjects are excluded from this cohort if any of the following additional criteria apply:
- Subjects taking strong OAT3 inhibitors (eg, probenecid) or adjust the dosing to 1 mg PO QD.
- Subjects with latent or active tuberculosis at screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792841
Contact: Amgen Call Center | 866-572-6436 | medinfo@amgen.com |
United States, California | |
Research Site | Recruiting |
Duarte, California, United States, 91010 | |
Research Site | Recruiting |
Los Angeles, California, United States, 90095 | |
United States, Georgia | |
Research Site | Recruiting |
Atlanta, Georgia, United States, 30322 | |
United States, Indiana | |
Research Site | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
United States, New York | |
Research Site | Recruiting |
New York, New York, United States, 10065 | |
Australia, New South Wales | |
Research Site | Recruiting |
Camperdown, New South Wales, Australia, 2050 | |
Research Site | Recruiting |
Randwick, New South Wales, Australia, 2031 | |
Australia, Victoria | |
Research Site | Recruiting |
Melbourne, Victoria, Australia, 3000 | |
Austria | |
Research Site | Recruiting |
Salzburg, Austria, 5020 | |
Research Site | Recruiting |
Wien, Austria, 1020 | |
Research Site | Recruiting |
Wien, Austria, 1090 | |
Belgium | |
Research Site | Recruiting |
Bruxelles, Belgium, 1200 | |
Research Site | Recruiting |
Gent, Belgium, 9000 | |
France | |
Research Site | Recruiting |
Villejuif Cedex, France, 94805 | |
Japan | |
Research Site | Recruiting |
Yokohama-shi, Kanagawa, Japan, 232-0024 | |
Research Site | Recruiting |
Chiba, Kashiwa-shi, Japan, 277-8577 | |
Netherlands | |
Research Site | Recruiting |
Rotterdam, Netherlands, 3015 GD | |
Singapore | |
Research Site | Recruiting |
Singapore, Singapore, 119074 | |
Research Site | Recruiting |
Singapore, Singapore, 169610 |
Study Director: | MD | Amgen |
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT03792841 |
Other Study ID Numbers: |
20180101 |
First Posted: | January 3, 2019 Key Record Dates |
Last Update Posted: | February 16, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study. |
Access Criteria: | Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below. |
URL: | https://www.amgen.com/datasharing |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
AMG 160 HLE-BiTE® mCRPC Metastatic Castration-resistant Prostate Cancer Prostate cancer PSMA BiTE® |
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