Safety Study of AMG 228 to Treat Solid Tumors

Study Overview
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Brief Summary
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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.

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

Conditions
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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

Intervention / Treatment
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* Drug: AMG 228


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 228 monotherapy<br>Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types. | Drug: AMG 228<br>* AMG 228 will be administered intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, Non-small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma, Carcinoma, Head and Neck, Transitional Cell Carinoma (TCC), Bladder, Colorectal, Colorectal Cancer (CRC)