Clinical trial · Interventional
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
NCT04822298CI-TRIAL-00078566terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Amgen made a business decision to discontinue AMG 160 20180273
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 160 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Exploration
- description
- The dose exploration part of the study will estimate the MTD and/or the RP2D.
- interventionNames
- Drug: AMG 160
- type
- EXPERIMENTAL
- label
- Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC
- description
- Participants with non-squamous non-small cell lung cancer (NSCLC) will be administered the RP2D identified from the dose exploration part of the study.
- interventionNames
- Drug: AMG 160
- type
- EXPERIMENTAL
- label
- Part 2: Dose Expansion - Cohort 2 Squamous NSCLC
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.