Bladder: Metastatic: Phase I: 2nd Line: 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

Title
Rainier B701-U22 (FIERCE-22)
Study Title

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

Site Link
Malignancy
Bladder, Urothelial, Metastatic Bladder Cancer, MBC, Transitional Cell Carcinoma
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd Line
Investigational Agent
vofatamab, pembrolizumab
Drug Class
FGFR3 inhibitor, PD-1 inhibitor
PI
Dan Vaena, MD
Sponsor
Rainier Therapeutics
Phase
Status
Key Eligibility Criteria
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
Objective
  • Primary: Safety and Tolerability; ORR
  • Secondary: DOR, DCR, PFS, OS, QOL, Biomarker
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Transitional Cell Carcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X