Safety Study of AMG 228 to Treat Solid Tumors

November 4, 2022 updated by: Amgen

A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 228 in Subjects With Selected Advanced Solid Tumors

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Research Site
  • Belgium
      • Leuven, Belgium, 3000
        • Research Site
  • France
      • Villejuif, France, 94805
        • Research Site
  • Germany
      • Heidelberg, Germany, 69120
        • Research Site
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Research Site
    • New York
      • New York, New York, United States, 10032
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: AMG 228
AMG 228 will be administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subject incidence of dose limiting toxicities (DLT)
Time Frame: 9 months
9 months
Subject incidence of treatment-emergent adverse events
Time Frame: 9 months
9 months
Subject incidence of treatment-related adverse events
Time Frame: 9 months
9 months
Subject incidence of clinically significant changes in vital signs and physical assessments
Time Frame: 9 months
9 months
Subject incidence of clinically significant changes in ECGs
Time Frame: 9 months
9 months
Subject incidence of clinically significant changes in clinical laboratory tests
Time Frame: 9 months
9 months
AMG 228 maximum observed concentration (Cmax)
Time Frame: 9 months
9 months
AMG 228 minimum observed concentration (Cmin)
Time Frame: 9 months
9 months
AMG 228 area under the concentration-time curve (AUC)
Time Frame: 9 months
9 months
AMG 228 half-life (t1/2)
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame: 9 months
9 months
Incidence of anti-AMG 228 antibody formation
Time Frame: 9 months
9 months
Activation status and changes in numbers of T regulator cells (Treg)
Time Frame: 9 months
9 months
Subject objective response per immune-related Response Criteria (irRC)
Time Frame: 9 months
9 months
Activation status of cytotoxic T lymphocytes (CTL)
Time Frame: 9 months
9 months
Changes in numbers of cytotoxic T lymphocytes (CTL)
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2015

Primary Completion (Actual)

December 12, 2016

Study Completion (Actual)

December 12, 2016

Study Registration Dates

First Submitted

April 3, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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