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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02437916




Registration number
NCT02437916
Ethics application status
Date submitted
3/04/2015
Date registered
8/05/2015
Date last updated
8/11/2022

Titles & IDs
Public title
Safety Study of AMG 228 to Treat Solid Tumors
Scientific title
A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 228 in Subjects With Selected Advanced Solid Tumors
Secondary ID [1] 0 0
20140131
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Malignancy 0 0
Advanced Solid Tumors 0 0
Cancer 0 0
Oncology 0 0
Oncology Patients 0 0
Tumors 0 0
Melanoma 0 0
Non-small Cell Lung Cancer 0 0
Squamous Cell Carcinoma of the Head and Neck 0 0
Transitional Cell Carinoma of Bladder 0 0
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 228

Experimental: AMG 228 monotherapy - Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types.


Treatment: Drugs: AMG 228
AMG 228 will be administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subject incidence of dose limiting toxicities (DLT)
Timepoint [1] 0 0
9 months
Primary outcome [2] 0 0
Subject incidence of treatment-emergent adverse events
Timepoint [2] 0 0
9 months
Primary outcome [3] 0 0
Subject incidence of treatment-related adverse events
Timepoint [3] 0 0
9 months
Primary outcome [4] 0 0
Subject incidence of clinically significant changes in vital signs and physical assessments
Timepoint [4] 0 0
9 months
Primary outcome [5] 0 0
Subject incidence of clinically significant changes in ECGs
Timepoint [5] 0 0
9 months
Primary outcome [6] 0 0
Subject incidence of clinically significant changes in clinical laboratory tests
Timepoint [6] 0 0
9 months
Primary outcome [7] 0 0
AMG 228 maximum observed concentration (Cmax)
Timepoint [7] 0 0
9 months
Primary outcome [8] 0 0
AMG 228 minimum observed concentration (Cmin)
Timepoint [8] 0 0
9 months
Primary outcome [9] 0 0
AMG 228 area under the concentration-time curve (AUC)
Timepoint [9] 0 0
9 months
Primary outcome [10] 0 0
AMG 228 half-life (t1/2)
Timepoint [10] 0 0
9 months
Secondary outcome [1] 0 0
Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timepoint [1] 0 0
9 months
Secondary outcome [2] 0 0
Incidence of anti-AMG 228 antibody formation
Timepoint [2] 0 0
9 months
Secondary outcome [3] 0 0
Activation status and changes in numbers of T regulator cells (Treg)
Timepoint [3] 0 0
9 months
Secondary outcome [4] 0 0
Subject objective response per immune-related Response Criteria (irRC)
Timepoint [4] 0 0
9 months
Secondary outcome [5] 0 0
Activation status of cytotoxic T lymphocytes (CTL)
Timepoint [5] 0 0
9 months
Secondary outcome [6] 0 0
Changes in numbers of cytotoxic T lymphocytes (CTL)
Timepoint [6] 0 0
9 months

Eligibility
Key inclusion criteria
* Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor
* Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active autoimmune disease, history of autoimmune disease
* Treatment with immune modulators including
* Use of warfarin, factor Xa inhibitors, or direct thrombin inhibitors
* Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days
* Major surgery within 28 days of study day 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/12/2016
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
France
State/province [5] 0 0
Villejuif
Country [6] 0 0
Germany
State/province [6] 0 0
Heidelberg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.
Trial website
https://clinicaltrials.gov/study/NCT02437916
Trial related presentations / publications
Tran B, Carvajal RD, Marabelle A, Patel SP, LoRusso PM, Rasmussen E, Juan G, Upreti VV, Beers C, Ngarmchamnanrith G, Schoffski P. Dose escalation results from a first-in-human, phase 1 study of glucocorticoid-induced TNF receptor-related protein agonist AMG 228 in patients with advanced solid tumors. J Immunother Cancer. 2018 Sep 25;6(1):93. doi: 10.1186/s40425-018-0407-x.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02437916