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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04822298
• Other study ID #: 20180273
• Status: Terminated
• Phase: Phase 1
• Start date: August 31, 2021
• Est. completion date: January 26, 2022

Study information

• Verified date: August 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 26, 2022
• Est. primary completion date: December 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• NSCLC

Intervention

Drug:
• AMG 160
AMG 160 administered as an intravenous (IV) infusion

Locations

Country	Name	City	State
Australia	Chris OBrien Lifehouse	Camperdown	New South Wales
Austria	Landeskrankenhaus Salzburg	Salzburg
Austria	Universitaetsklinikum Allgemeines Krankenhaus Wien	Wien
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who Experience One or More Dose-limiting Toxicities (DLTs)		28 days
Primary	Number of Participants who Experience One or More Treatment-emergent Adverse Event (TEAE)		Up to 3 years
Primary	Number of Participants who Experience One or More Treatment-related Adverse Events		Up to 3 years
Primary	Number of Participants who Experience Clinically Significant Changes in Vital Signs		Up to 3 years
Primary	Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Tests		Up to 3 years
Secondary	Objective Response (OR) per Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1		Up to 3 years
Secondary	Overall Survival		Up to 3 years
Secondary	Progression-free Survival (PFS)		Up to 3 years
Secondary	Time to Response		Up to 3 years
Secondary	Time to Progression		Up to 3 years
Secondary	Duration of Response		Up to 3 years
Secondary	Time to Subsequent Therapy		Up to 3 years

External Links

•   AmgenTrials clinical trials website