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Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT04822298•Amgen

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (4)

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

Landeskrankenhaus Salzburg

Salzburg, Austria

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, Austria

Key Dates

Start Date

August 31, 2021

Primary Completion Date

December 8, 2021

Completion Date

January 26, 2022

Last Updated

July 5, 2024

Enrollment

ACTUAL participants

Conditions

Non-small Cell Lung CancerNSCLC

Interventions

AMG 160

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Magnetic Resonance Imaging of the Lung: Oncological Applications

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers