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Safety Study of AMG 228 to Treat Solid Tumors

Primary Purpose

Advanced Malignancy, Advanced Solid Tumors, Cancer

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AMG 228
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Malignancy focused on measuring Melanoma, Non-small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma, Carcinoma, Head and Neck, Transitional Cell Carinoma (TCC), Bladder, Colorectal, Colorectal Cancer (CRC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor
  • Adequate hematological, renal, hepatic, and coagulation laboratory assessments

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AMG 228 monotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Subject incidence of dose limiting toxicities (DLT)
Subject incidence of treatment-emergent adverse events
Subject incidence of treatment-related adverse events
Subject incidence of clinically significant changes in vital signs and physical assessments
Subject incidence of clinically significant changes in ECGs
Subject incidence of clinically significant changes in clinical laboratory tests
AMG 228 maximum observed concentration (Cmax)
AMG 228 minimum observed concentration (Cmin)
AMG 228 area under the concentration-time curve (AUC)
AMG 228 half-life (t1/2)

Secondary Outcome Measures

Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Incidence of anti-AMG 228 antibody formation
Activation status and changes in numbers of T regulator cells (Treg)
Subject objective response per immune-related Response Criteria (irRC)
Activation status of cytotoxic T lymphocytes (CTL)
Changes in numbers of cytotoxic T lymphocytes (CTL)

Full Information

First Posted
April 3, 2015
Last Updated
November 4, 2022
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02437916
Brief Title
Safety Study of AMG 228 to Treat Solid Tumors
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Study Start Date
April 21, 2015 (Actual)
Primary Completion Date
December 12, 2016 (Actual)
Study Completion Date
December 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Malignancy, Advanced Solid Tumors, Cancer, Oncology, Oncology Patients, Tumors, Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Transitional Cell Carinoma of Bladder, Colorectal Cancer
Keywords
Melanoma, Non-small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma, Carcinoma, Head and Neck, Transitional Cell Carinoma (TCC), Bladder, Colorectal, Colorectal Cancer (CRC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMG 228 monotherapy
Arm Type
Experimental
Arm Description
Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types.
Intervention Type
Drug
Intervention Name(s)
AMG 228
Intervention Description
AMG 228 will be administered intravenously
Primary Outcome Measure Information:
Title
Subject incidence of dose limiting toxicities (DLT)
Time Frame
9 months
Title
Subject incidence of treatment-emergent adverse events
Time Frame
9 months
Title
Subject incidence of treatment-related adverse events
Time Frame
9 months
Title
Subject incidence of clinically significant changes in vital signs and physical assessments
Time Frame
9 months
Title
Subject incidence of clinically significant changes in ECGs
Time Frame
9 months
Title
Subject incidence of clinically significant changes in clinical laboratory tests
Time Frame
9 months
Title
AMG 228 maximum observed concentration (Cmax)
Time Frame
9 months
Title
AMG 228 minimum observed concentration (Cmin)
Time Frame
9 months
Title
AMG 228 area under the concentration-time curve (AUC)
Time Frame
9 months
Title
AMG 228 half-life (t1/2)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame
9 months
Title
Incidence of anti-AMG 228 antibody formation
Time Frame
9 months
Title
Activation status and changes in numbers of T regulator cells (Treg)
Time Frame
9 months
Title
Subject objective response per immune-related Response Criteria (irRC)
Time Frame
9 months
Title
Activation status of cytotoxic T lymphocytes (CTL)
Time Frame
9 months
Title
Changes in numbers of cytotoxic T lymphocytes (CTL)
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor Adequate hematological, renal, hepatic, and coagulation laboratory assessments 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Research Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30253804
Citation
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.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

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Safety Study of AMG 228 to Treat Solid Tumors

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