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

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy 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).

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