A Study to Assess the Safety, Pharmacokinetics and Effectiveness of AGS-16C3F Monotherapy in Subjects With Renal Cell Carcinoma (RCC) of Clear Cell or Papillary Histology

Inclusion Criteria

• •Dose determination cohorts: Histologically confirmed diagnosis of metastatic RCC of either clear cell or non-clear histology.
• •* Tumors with clear cell histology: subject must have progressed after at least one anti-vascular endothelial growth factor receptor (anti-VEGFR) therapy
• •* Tumors with non-clear cell histology must be ectonucleotide pyrophosphatase/phosphodiesterase family member 3 (ENPP3) positive at pre-screening. This sub-group does not have any prior therapy requirement.
• •Dose expansion cohorts: Histologically confirmed diagnosis of metastatic RCC of either clear cell or papillary histology
• •* Tumors with clear cell histology: subject must have progressed after at least one anti-VEGFR therapy
• •* Tumors with papillary histology: includes unclassified histology with papillary features and must be ENPP3 positive at pre-screening. This sub-group does not have any prior therapy requirement.
• •Measurable disease according to Response Criteria for Solid Tumors (RECIST Version 1.1)
• •Eastern Cooperative Group (ECOG) performance status of 0-1
• •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 4 weeks after the last AGS-16C3F infusion administration