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

NCT ID: NCT04822298

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2022-01-26

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).

Conditions

Non-small Cell Lung Cancer; NSCLC

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Dose Exploration

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

Group Type: EXPERIMENTAL

AMG 160

Intervention Type: DRUG

AMG 160 administered as an intravenous (IV) infusion

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.

Group Type: EXPERIMENTAL

AMG 160

Intervention Type: DRUG

AMG 160 administered as an intravenous (IV) infusion

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.

Group Type: EXPERIMENTAL

AMG 160

Intervention Type: DRUG

AMG 160 administered as an intravenous (IV) infusion

Interventions

AMG 160

AMG 160 administered as an intravenous (IV) infusion

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

Landeskrankenhaus Salzburg

Salzburg, , Austria

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, , Austria

Countries

United States; Australia; Austria

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20180273

Identifier Type: -

Identifier Source: org_study_id