Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
With
Agensys, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amenable to cure by surgery or other means.
Non-measurable or measurable disease according to Response Criteria for Solid Tumors (RECIST Version 1.1)
Eastern Cooperative Group (ECOG) performance status of 0-1
Negative pregnancy test (women of childbearing potential)
Hematologic function, as follows:
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelet count ≥ 100 x 109/L
* Hemoglobin ≥ 9 g/dL (transfusions are allowed)
Renal function, as follows:
* creatinine ≤ 1.5 x upper limit of normal (ULN), or calculated glomerular filtration rate (GFR) \> 50 mL/min if creatinine \> 1.5x ULN
Hepatic function, as follows:
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5x ULN if known liver metastases
* Total bilirubin ≤ 1.5 x ULN
International Normalized Ratio (INR) \< 1.3 (or ≤ 3.0 if on therapeutic anticoagulation)
Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study and for four weeks after the last AGS-16M8F infusion administration
You may not be if
Past or present documented central nervous system (CNS) tumor or CNS metastasis
Use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening
History of thromboembolic events and bleeding disorders ≤ 3 months (e.g., DVT or PE)
Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrythmias not controlled by outpatient medication
Major surgery (that requires general anesthesia) within 4 weeks of study enrollment
Women who are pregnant (confirmed by positive pregnancy test) or lactating
Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen
Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
Clareo Health | A First in Man Study to Determine the Safety at Various Dose Levels of AGS-16M8F in Advanced Kidney Cancer
