Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer
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).
Checked against the public recordLast updated Jul 5, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Amgen
- Interventions being studied
- Drug: AMG 160
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Texas MD Anderson Cancer CenterHouston, Texas
- Chris OBrien LifehouseCamperdown, New South Wales
- Landeskrankenhaus SalzburgSalzburg
- Universitaetsklinikum Allgemeines Krankenhaus WienVienna
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 5, 2024. Always confirm current availability with the study team.