A First in Man Study to Determine the Safety at Various Dose Levels of AGS-16M8F in Advanced Kidney Cancer

Astellas

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics of AGS-16M8F; Renal Cell Carcinoma

Treatments: Drug: AGS-16M8F

Study type: Interventional

Funder types: Industry

Identifiers

NCT01114230

2009002

Details and patient eligibility

About

The purpose of this dose escalation study is to examine the safety and pharmacokinetics (PK) of AGS-16M8F administered in subjects with advanced renal cell carcinoma.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

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 screening

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 9 patient groups

Dose Level 1

Experimental group

Treatment:

Drug: AGS-16M8F

Dose Level 2

Experimental group

Treatment:

Drug: AGS-16M8F

Dose Level 3

Experimental group

Treatment:

Drug: AGS-16M8F

Dose Level 4

Experimental group

Treatment:

Drug: AGS-16M8F

Dose Level 5

Experimental group

Treatment:

Drug: AGS-16M8F

Dose Level 6

Experimental group

Treatment:

Drug: AGS-16M8F

Dose Level 7

Experimental group

Treatment:

Drug: AGS-16M8F

Dose Level 8

Experimental group

Treatment:

Drug: AGS-16M8F

Dose Level 9

Experimental group

Treatment:

Drug: AGS-16M8F