Status:
TERMINATED
Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer
Lead Sponsor:
Amgen
Conditions:
Non-small Cell Lung Cancer
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04822298
Start Date
August 31 2021
End Date
January 26 2022
Last Update
July 5 2024
Active Locations (4)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
2
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia, 2050
3
Landeskrankenhaus Salzburg
Salzburg, Austria, 5020
4
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, Austria, 1090