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Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT04822298
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
This study aims to evaluate the safety and tolerability of AMG 160 and to evaluate the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer NSCLC Drug: AMG 160 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With Non-Small Cell Lung Cancer
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : February 18, 2026
Estimated Study Completion Date : February 18, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Dose Exploration
The dose exploration part of the study will estimate the MTD and/or the RP2D.
 Drug: AMG 160
AMG 160 administered as an intravenous (IV) infusion
Experimental: Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC
Participants with non-squamous non-small cell lung cancer (NSCLC) will be administered the RP2D identified from the dose exploration part of the study.
 Drug: AMG 160
AMG 160 administered as an intravenous (IV) infusion
Experimental: Part 2: Dose Expansion - Cohort 2 Squamous NSCLC
Participants with squamous NSCLC will be administered the RP2D identified from the dose exploration part of the study.
 Drug: AMG 160
AMG 160 administered as an intravenous (IV) infusion


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants who Experience One or More Dose-limiting Toxicities (DLTs) [ Time Frame: 28 days ]
  2. Number of Participants who Experience One or More Treatment-emergent Adverse Event (TEAE) [ Time Frame: Up to 3 years ]
  3. Number of Participants who Experience One or More Treatment-related Adverse Events [ Time Frame: Up to 3 years ]
  4. Number of Participants who Experience Clinically Significant Changes in Vital Signs [ Time Frame: Up to 3 years ]
  5. Number of Participants who Experience Clinically Significant Changes in Electrocardiograms (ECGs) [ Time Frame: Up to 3 years ]
  6. Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Tests [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Maximum Serum Concentration (Cmax) of AMG 160 [ Time Frame: Up to 24 weeks ]
  2. Minimum Serum Concentration (Cmin) of AMG 160 [ Time Frame: Up to 24 weeks ]
  3. Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 160 [ Time Frame: Up to 24 weeks ]
  4. Accumulation Ratio of AMG 160 [ Time Frame: Up to 24 weeks ]
  5. Half-life (t1/2) of AMG 160 [ Time Frame: Up to 24 weeks ]
  6. Objective Response (OR) per Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 3 years ]
  7. Overall Survival [ Time Frame: Up to 3 years ]
  8. Progression-free Survival (PFS) [ Time Frame: Up to 3 years ]
  9. Time to Response [ Time Frame: Up to 3 years ]
  10. Time to Progression [ Time Frame: Up to 3 years ]
  11. Duration of Response [ Time Frame: Up to 3 years ]
  12. Time to Subsequent Therapy [ Time Frame: Up to 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  • Histologically or cytologically confirmed stage 4 or recurrent non-squamous NSCLC (Part 1); histologically or cytologically. confirmed stage 4 or recurrent NSCLC (Part 2 only, squamous cell histology/cytology allowed in Part 2).
  • Without a driver mutation: disease progression following at least one line of prior chemotherapy and at least 1 prior anti-programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PDL1) therapy.
  • With a driver mutation must experience disease progression on at least 1 targeted therapeutic agent to be eligible.
  • Detectable prostate-specific membrane antigen (PSMA) expression by PSMA positron emission tomography (PET)/computed tomography (CT) imaging.
  • Measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0- 2.

Exclusion Criteria:

  • Radiographic evidence of intratumor cavitation, major blood vessel invasion or encasement by cancer.
  • Untreated or symptomatic brain metastases and leptomeningeal disease.
  • History of hemoptysis within 3 months prior to first dose.
  • History or evidence of gastrointestinal inflammatory bowel disease (ulcerative colitis or Crohn disease).
  • Myocardial infarction, unstable angina, cardiac arrhythmias requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months prior to start of dosing.
  • Vasculitis or grade 3/4 gastrointestinal bleeding within 3 months prior to first dose; vascular disease (eg, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months of first dose.
  • Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to start of dosing.
  • Interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with treatment.
  • Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
  • Chronic systemic corticosteroid therapy or any other immunosuppressive therapies unless stopped 7 days prior to first dose.
  • Any biological therapy or immunotherapy within 3 weeks of start of first dose.
  • Major surgery within 4 weeks of first dose.
  • Infection requiring IV antimicrobials for management within 7 days of dosing.
  • Known human immunodeficiency virus (HIV) infection, hepatitis C infection.
  • Active autoimmune disease
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04822298


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Australia, New South Wales
Chris OBrien Lifehouse Recruiting
Camperdown, New South Wales, Australia, 2050
Austria
Landeskrankenhaus Salzburg Recruiting
Salzburg, Austria, 5020
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04822298    
Other Study ID Numbers: 20180273
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 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 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
AMG 160
Phase 1b
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms