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TerminatedNCT02437916Updated Nov 8, 2022

Safety Study of AMG 228 to Treat Solid Tumors

A Phase 1 interventional study of AMG 228 in Advanced Malignancy, Advanced Solid Tumors and Cancer, sponsored by Amgen. Terminated at 7 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by Amgen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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)
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 30 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • DrugAMG 228

    AMG 228 will be administered intravenously

06

What researchers measure

Primary outcomes

  1. Subject incidence of dose limiting toxicities (DLT)

    Time frame: 9 months

  2. Subject incidence of treatment-emergent adverse events

    Time frame: 9 months

  3. Subject incidence of treatment-related adverse events

    Time frame: 9 months

  4. Subject incidence of clinically significant changes in vital signs and physical assessments

    Time frame: 9 months

  5. Subject incidence of clinically significant changes in ECGs

    Time frame: 9 months

  6. Subject incidence of clinically significant changes in clinical laboratory tests

    Time frame: 9 months

  7. AMG 228 maximum observed concentration (Cmax)

    Time frame: 9 months

  8. AMG 228 minimum observed concentration (Cmin)

    Time frame: 9 months

  9. AMG 228 area under the concentration-time curve (AUC)

    Time frame: 9 months

  10. AMG 228 half-life (t1/2)

    Time frame: 9 months

Secondary outcomes

  1. Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Time frame: 9 months

  2. Incidence of anti-AMG 228 antibody formation

    Time frame: 9 months

  3. Activation status and changes in numbers of T regulator cells (Treg)

    Time frame: 9 months

  4. Subject objective response per immune-related Response Criteria (irRC)

    Time frame: 9 months

  5. Activation status of cytotoxic T lymphocytes (CTL)

    Time frame: 9 months

  6. Changes in numbers of cytotoxic T lymphocytes (CTL)

    Time frame: 9 months

07

Study locations

7 sites
  • Research Site
    La Jolla, California 92093, United States
  • Research Site
    New Haven, Connecticut 06520, United States
  • Research Site
    New York, New York 10032, United States
  • Research Site
    Parkville, Victoria 3050, Australia
  • Research Site
    Leuven, 3000, Belgium
  • Research Site
    Villejuif, 94805, France
  • Research Site
    Heidelberg, 69120, Germany
08

References and documents

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. PubMed 30253804 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02437916
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
May 8, 2015
Start date
Apr 21, 2015
Primary completion
Dec 12, 2016
Completion
Dec 12, 2016
Last update
Nov 8, 2022

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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