A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement

Secondary

• Duration of response (DOR) assessed by Independent Review Committee per RECIST v1.1.

  Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.

• Number of patients with adverse events and serious adverse events.

  Time frame: Every cycle (4-week cycles) until study discontinuation, approximately 24 months.

• Number of patients with dose interruptions.

  Time frame: Every 28-day cycle until end of treatment, approximately 24 months.

• Number of patients with dose reductions.

  Time frame: Every 28-day cycle until end of treatment, approximately 24 months.

• Number of patients with dose discontinuations.

  Time frame: Every 28-day cycle until end of treatment, approximately 24 months.

• Objective Response Rate (ORR) as assessed by Investigator per RECIST v1.1.

  Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.

• Duration of Response (DOR) as assessed by Investigator per RECIST v1.1.

  Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months

• Disease control rate (DCR) as assessed by Investigator and Independent Review Committee per RECIST v1.1.

  Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.

• Progression-free survival (PFS) as assessed by Investigator and Independent Review Committee per RECIST v1.1.

  Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months

• Overall survival (OS).

  Time frame: Up to approximately 36 months.

• Time to response (TTR) assessed by Investigator and Independent Review Committee per RECIST v1.1.

  Time frame: Up to approximately 36 months.

• Time to progression (TTP) assessed by Investigator and Independent Review Committee per RECIST v1.1.

  Time frame: Up to approximately 36 months

• Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)

  Time frame: [Time Frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)]

• Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC)

  Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)

• Pharmacokinetic parameters including half-life (t1/2)

  Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)

• Change from baseline in quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).

  Time frame: Approximately every 4 weeks during treatment, approximately 24 months

• Time to deterioration (TTD).

  Time frame: Up to approximately 36 months.

• FGFR2 gene status in plasma circulating tumor deoxyribonucleic acid (ctDNA) and tumor tissue.

  Time frame: Every cycle (4-week cycles) through Cycle 3 and every other cycle thereafter until study discontinuation, approximately 24 months.

• Pharmacodynamic parameters including changes in fibroblast growth factor 23 (FGF-23).

  Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months.

• Pharmacodynamic parameters including changes in carcinoembryonic antigen (CEA)

  Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months

• Pharmacodynamic parameters including changes in cancer antigen 19-9 (CA 19-9)

  Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months

• Correlation between FGFR2 genotype by central tissue assessment and antitumor response, as measured by Objective Response Rate (ORR).

  Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.