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

Primary Purpose

Non-small Cell Lung Cancer, NSCLC

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AMG 160

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring AMG 160, Phase 1b

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Texas MD Anderson Cancer Center
Chris OBrien Lifehouse
Landeskrankenhaus Salzburg
Universitaetsklinikum Allgemeines Krankenhaus Wien

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Part 1: Dose Exploration

Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC

Part 2: Dose Expansion - Cohort 2 Squamous NSCLC

Arm Description

The dose exploration part of the study will estimate the MTD and/or the RP2D.

Participants with non-squamous non-small cell lung cancer (NSCLC) will be administered the RP2D identified from the dose exploration part of the study.

Participants with squamous NSCLC will be administered the RP2D identified from the dose exploration part of the study.

Outcomes

Primary Outcome Measures

Number of Participants who Experience One or More Dose-limiting Toxicities (DLTs)

Number of Participants who Experience One or More Treatment-emergent Adverse Event (TEAE)

Number of Participants who Experience One or More Treatment-related Adverse Events

Number of Participants who Experience Clinically Significant Changes in Vital Signs

Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Tests

Secondary Outcome Measures

Maximum Serum Concentration (Cmax) of AMG 160

Minimum Serum Concentration (Cmin) of AMG 160

Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 160

Accumulation Ratio of AMG 160

Half-life (t1/2) of AMG 160

Objective Response (OR) per Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Overall Survival

Progression-free Survival (PFS)

Time to Response

Time to Progression

Duration of Response

Time to Subsequent Therapy

Full Information

NCT ID

NCT04822298

First Posted

March 26, 2021

Last Updated

April 26, 2023

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT04822298

Brief Title

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

Official Title

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Terminated

Why Stopped

Amgen made a business decision to discontinue AMG 160 20180273

Study Start Date

August 31, 2021 (Actual)

Primary Completion Date

December 8, 2021 (Actual)

Study Completion Date

January 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer, NSCLC

Keywords

AMG 160, Phase 1b

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: Dose Exploration

Arm Type

Experimental

Arm Description

The dose exploration part of the study will estimate the MTD and/or the RP2D.

Arm Title

Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC

Arm Type

Experimental

Arm Description

Participants with non-squamous non-small cell lung cancer (NSCLC) will be administered the RP2D identified from the dose exploration part of the study.

Arm Title

Part 2: Dose Expansion - Cohort 2 Squamous NSCLC

Arm Type

Experimental

Arm Description

Participants with squamous NSCLC will be administered the RP2D identified from the dose exploration part of the study.

Intervention Type

Drug

Intervention Name(s)

AMG 160

Intervention Description

AMG 160 administered as an intravenous (IV) infusion

Primary Outcome Measure Information:

Title

Number of Participants who Experience One or More Dose-limiting Toxicities (DLTs)

Time Frame

28 days

Title

Number of Participants who Experience One or More Treatment-emergent Adverse Event (TEAE)

Time Frame

Up to 3 years

Title

Number of Participants who Experience One or More Treatment-related Adverse Events

Time Frame

Up to 3 years

Title

Number of Participants who Experience Clinically Significant Changes in Vital Signs

Time Frame

Up to 3 years

Title

Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Tests

Time Frame

Up to 3 years

Secondary Outcome Measure Information:

Title

Maximum Serum Concentration (Cmax) of AMG 160

Time Frame

Up to 24 weeks

Title

Minimum Serum Concentration (Cmin) of AMG 160

Time Frame

Up to 24 weeks

Title

Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 160

Time Frame

Up to 24 weeks

Title

Accumulation Ratio of AMG 160

Time Frame

Up to 24 weeks

Title

Half-life (t1/2) of AMG 160

Time Frame

Up to 24 weeks

Title

Objective Response (OR) per Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Time Frame

Up to 3 years

Title

Overall Survival

Time Frame

Up to 3 years

Title

Progression-free Survival (PFS)

Time Frame

Up to 3 years

Title

Time to Response

Time Frame

Up to 3 years

Title

Time to Progression

Time Frame

Up to 3 years

Title

Duration of Response

Time Frame

Up to 3 years

Title

Time to Subsequent Therapy

Time Frame

Up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Chris OBrien Lifehouse

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Landeskrankenhaus Salzburg

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Universitaetsklinikum Allgemeines Krankenhaus Wien

City

Wien

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing URL

http://www.amgen.com/datasharing

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

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