This is an open-label, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of YF087 in subjects with Microsatellite Instability-High (MSI-H) or Mismatch Repair-Deficient (dMMR) advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Dosage form: Tablet • Administration route: Oral, once a day
Number of subjects participants with adverse events
Number of subjects participants with adverse events
Time frame: From enrollment to 30 days after last dose
Subject incidence of Dose-limiting toxicities (DLT)
Time frame: From enrollment to Cycle 1 Day 21
Objective response rate (ORR)
Time frame: From enrollment to the end of treatment, about 1 year
Disease control rate (DCR)-assessed by IRC and investigators
Time frame: From enrollment to the end of treatment, about 1 year
Progression free survival (PFS)
Time frame: From enrollment to the end of treatment, about 1 year
Duration of Response (DOR)
Time frame: From enrollment to the end of treatment, about 1 year
Change from baseline in QT/QTc interval
Time frame: On Cycle 0 Day 1 and Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: area under the concentration-time curve from the time of dosing to time t (AUC0-t)
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: area under the concentration-time curve from time 0 to infinity (AUC0-∞)
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
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Primary PK parameters: Mean residence time (MRT)
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: maximum concentration (Cmax)
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: Time to maximum concentration (Tmax)
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: t1/2
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)
Primary PK parameters: Apparent Volume of Distribution (Vz/F)
Time frame: From Cycle 0 Day 1 to Cycle 0 Day 7 and on Cycle 2 Day 1 (Cycle 0 is 7 days and the rest cycle is 21 days)