A Multi-center, Open Label, Randomized Phase 2 Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma

The purpose of this study is to evaluate the progression free survival (PFS), based on investigator radiologic review, of AGS-16C3F compared to axitinib in subjects with metastatic renal cell carcinoma.

Inclusion Criteria:
• Histologically confirmed diagnosis of metastatic RCC (Non-clear subjects must be ENPP3 positive, defined as IHC H-score ≥15)
• Has evidence of progression on or after the last regimen received: Clear cell subject: must have received at least 2 prior systemic regimens, one of which is an anti-VEGF agent. Non-clear cell subject: must have received at least one prior anti-VEGF regimen
• Has measurable disease according to Response Criteria for Solid Tumors (RECIST v.1.1)
• Has accessible archive tumor tissue from primary tumor or metastatic site (excluding bone), from which at least 5 tumor tissue sections (4 microns) can be provided for the study.
- If no archive tissue is available, a biopsy may be performed to obtain tissue.
Phase I/II
Brendan Curti, M.D.
Agensys, Inc.
  • Oncology and Hematology Care Eastside