Overview
Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer
Status:
Recruiting
Recruiting
Trial end date:
2026-02-18
2026-02-18
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Amgen
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