MOLECULARLY TARGETED: FGFR-mutant or fusions: FGFR inhibitor: FIGHT-207

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

Title
Incyte INCB 54828-207- FGFR Basket
Study Title

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

Site Link
Malignancy
Solid Tumors: Breast, Lung (NSCLC), Colon, Prostate, Bladder, Kidney, Esophagus, Stomach (Gastric), Liver (HCC), Cervical, Endometrial, Ovarian, Skin, Head and Neck (SCCHN), Bladder, Kidney (renal cell), Pancreatic, Rectal, Brain (GBM, glioblastoma)
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
Following all effecive therapy (late line)
Investigational Agent
Pemigatinib
Drug Class
FGFR inhibitor
PI
Dan Vaena, MD
Sponsor
Incyte Corporation
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Metastatic or surgically unresectable solid tumor
  • Measurable disease
  • Documentation of an FGFR1-3 gene mutation or translocation
  • At least 1 prior line of therapy with progression
  • No other therapy available likely to provide clinical benefit
  • ECOG PS 0-2
  • No other FGFR inhibitors within last 6 months
  • No clinically significant corneal or retinal disorder
  • No untreated CNS disease (except primary brain cancer)
  • No additional malignancy at current time requiring active treatment
  • No history of calcium or phosphate disorder or systemic mineral imbalance
  • No clinically significant cardiac disease
  • No active HBV/HCV
  • No known HIV
Objective
  • Primary
    • ORR
  • Secondary
    • PFS
    • DoR
    • OS
    • Safety
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
FGFR 1,2,3 mutated or FGFR 1,2,3 fusion/translocation
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X