Safety Study of AMG 228 to Treat Solid Tumors

Sponsor

Amgen (Industry)

Overall Status

Terminated

CT.gov ID

NCT02437916

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

4.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: AMG 228	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	La Jolla	California	United States	92093
2	Research Site	New Haven	Connecticut	United States	06520
3	Research Site	New York	New York	United States	10032
4	Research Site	Parkville	Victoria	Australia	3050
5	Research Site	Leuven		Belgium	3000
6	Research Site	Villejuif		France	94805
7	Research Site	Heidelberg		Germany	69120