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A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M8F Monotherapy in Subjects With Advanced Renal Cell Carcinoma

Phase 1
18 Years
Not Enrolling
Renal Cell Carcinoma, Pharmacokinetics of AGS-16M8F

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Trial Information

A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M8F Monotherapy in Subjects With Advanced Renal Cell Carcinoma

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety assessed by recording adverse events, vital signs and laboratory assessments

Outcome Time Frame:

For 12 weeks during treatment period and up to 4 weeks follow up

Safety Issue:


Principal Investigator

Chief Medical Officer

Investigator Role:

Study Director

Investigator Affiliation:

Agensys, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

November 2012

Related Keywords:

  • Renal Cell Carcinoma
  • Pharmacokinetics of AGS-16M8F
  • Advanced Renal Cell Carcinoma
  • Advanced Kidney Cancer
  • AGS-16M8F
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Seattle Cancer Care AllianceSeattle, Washington  98109