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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04822298
Registration number
NCT04822298
Ethics application status
Date submitted
26/03/2021
Date registered
30/03/2021
Date last updated
20/12/2023
Titles & IDs
Public title
Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer
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Scientific title
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With Non-Small Cell Lung Cancer
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Secondary ID [1]
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20180273
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer
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NSCLC
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AMG 160
Experimental: Part 1: Dose Exploration - The dose exploration part of the study will estimate the MTD and/or the RP2D.
Experimental: Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC - Participants with non-squamous non-small cell lung cancer (NSCLC) will be administered the RP2D identified from the dose exploration part of the study.
Experimental: Part 2: Dose Expansion - Cohort 2 Squamous NSCLC - Participants with squamous NSCLC will be administered the RP2D identified from the dose exploration part of the study.
Treatment: Drugs: AMG 160
AMG 160 administered as an intravenous (IV) infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants who Experience One or More Dose-limiting Toxicities (DLTs)
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Assessment method [1]
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Timepoint [1]
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28 days
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Primary outcome [2]
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Number of Participants who Experience One or More Treatment-emergent Adverse Event (TEAE)
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Assessment method [2]
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Timepoint [2]
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Up to 3 years
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Primary outcome [3]
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Number of Participants who Experience One or More Treatment-related Adverse Events
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Assessment method [3]
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Timepoint [3]
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Up to 3 years
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Primary outcome [4]
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Number of Participants who Experience Clinically Significant Changes in Vital Signs
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Assessment method [4]
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Timepoint [4]
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Up to 3 years
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Primary outcome [5]
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Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Tests
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Assessment method [5]
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Timepoint [5]
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Up to 3 years
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Secondary outcome [1]
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Objective Response (OR) per Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
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Assessment method [1]
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Overall Survival
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Assessment method [2]
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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Progression-free Survival (PFS)
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Assessment method [3]
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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Time to Response
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Assessment method [4]
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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Time to Progression
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Assessment method [5]
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Timepoint [5]
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Up to 3 years
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Secondary outcome [6]
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Duration of Response
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Assessment method [6]
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Timepoint [6]
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Up to 3 years
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Secondary outcome [7]
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Time to Subsequent Therapy
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Assessment method [7]
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Timepoint [7]
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Up to 3 years
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/01/2022
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Sample size
Target
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Accrual to date
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Final
3
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Chris OBrien Lifehouse - Camperdown
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Texas
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Country [2]
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Austria
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State/province [2]
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Salzburg
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Country [3]
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Austria
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State/province [3]
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Wien
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04822298
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04822298
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