Rainier B701-U22 (FIERCE-22)
A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined With Pembrolizumab in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Who Have Progressed Following Platinum-based Chemotherapy
Bladder, Urothelial, Metastatic Bladder Cancer, MBC, Transitional Cell Carcinoma
FGFR3 inhibitor, PD-1 inhibitor
Key Eligibility Criteria Details
- Have histologically confirmed locally advanced (on TNM staging: T4b and any N, or any T and N2-3) or metastatic transitional cell carcinoma of the urothelium, including of the urinary bladder, urethra, ureter, and/or renal pelvis.
- Have progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
- Have measurable disease according to RECIST v1.1.
- Has available archival tumor or is willing to undergo diagnostic biopsy at screening
- ECOG PS 0-1
- No history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on the Screening chest CT scan
- No CNS disease or any history of brain metastases
- No autoimmune disease
- No history of significant coagulation or platelet disorder in last 12 months