Clinical Trial: Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)

Brief Summary: To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome:

  • Maximum tolerated dose(MTD) [ Time Frame: Up to 2 years ]
    The MTD is defined as the maximum dose at which the incidence of DLTs during Cycle 1 is below 20%, or the maximum dose administered, whichever is achieved first during dose escalation
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Up to 2 years ]
  • Number of subjects with serious adverse events as a measure of safety and tolerability [ Time Frame: Up to 2 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cmax (maximum observed drug concentration in measured matrix after single dose administration) [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • AUC(0-tlast) AUC from time 0 to the last data point >LLOQ [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • AUC)0-504 (AUC from zero to 504 hours post infusion) [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • AUC (area under the concentration vs. time curve from zero to infinity after single (first) [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • Cmax,md (maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval) [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • AUC(0-tlast)md (AUC from time 0 to the last data point >LLOQ after multiple dosing) [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • AUC(0-504)md [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • FGFR2 levels in tumor tissue sample [ Time Frame: Screening ]
  • CK18 levels in tumor tissue sample [ Time Frame: Screening, Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose and end of infusion. ]
  • Nucleosome level in plasma [ Time Frame: Screening, Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose and end of infusion. ]
  • Development of anti-drug antibodies (ADAs) in plasma as an indicator of immunogenicity [ Time Frame: Cycle 1: Day 1: before infusion (pre-dose), Day 8 ]
  • Tumor response [ Time Frame: Screening, Day 15 (± 7 days) of Cycle 2 and every even subsequent Cycle (i.e. Cycles 2, 4, 6, 8, etc.) ]


Original Secondary Outcome:

  • Cmax (maximum observed drug concentration in measured matrix after single dose administration) [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • AUC(0-tlast) AUC from time 0 to the last data point >LLOQ [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • AUC)0-504 (AUC from zero to 504 hours post infusion) [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • AUC (area under the concentration vs. time curve from zero to infinity after single (first) [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • Cmax,md (maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval) [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • AUC(0-tlast)md (AUC from time 0 to the last data point >LLOQ after multiple dosing) [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • AUC(0-504)md [ Time Frame: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion ]
  • FGFR2 levels in tumor tissue sample [ Time Frame: Screening, Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose and end of infusion. ]
  • CK18 levels in tumor tissue sample [ Time Frame: Screening, Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose and end of infusion. ]
  • Nucleosome level in plasma [ Time Frame: Screening, Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose and end of infusion. ]
  • Development of anti-drug antibodies (ADAs) in plasma as an indicator of immunogenicity [ Time Frame: Cycle 1: Day 1: before infusion (pre-dose), Day 8 ]
  • Tumor response [ Time Frame: Screening, Day 15 (± 7 days) of Cycle 2 and every even subsequent Cycle (i.e. Cycles 2, 4, 6, 8, etc.) ]


Information By: Bayer

Dates:
Date Received: February 16, 2015
Date Started: March 2015
Date Completion:
Last Updated: August 30, 2016
Last Verified: August 2016