Advanced Malignancy, Advanced Solid Tumors, Cancer, Colorectal Cancer, Melanoma, Non-small Cell Lung Cancer, Oncology, Oncology Patients, Squamous Cell Carcinoma of the Head and Neck, Transitional Cell Carinoma of Bladder, Tumors
Conditions
Keywords
Melanoma, Non-small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma, Carcinoma, Head and Neck, Transitional Cell Carinoma (TCC), Bladder, Colorectal, Colorectal Cancer (CRC)
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.
Interventions
DRUGAMG 228
AMG 228 will be administered intravenously
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AMG 228 half-life (t1/2) | 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | 9 months |
Countries
Australia, Belgium, France, Germany, United States
Outcome results
None listed