This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ASKC189 in in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
ASKC189 for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met.
Peking University Cancer Hospital
Beijing, China
Shanghai East Hospital
Shanghai, China
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
DLT is short for Dose Limiting Toxicity, dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Time frame: Up to 21 days following first dose
Number of participants with adverse events and serious adverse events as assessed by CTCAE v6.0
AE refers to any untoward medical occurrence or deterioration of existing medical event after the investigational treatment, whether or not considered related to the study treatment.
Time frame: Up to 30 days following last dose
Characterization of the PK profile of ASKC189
AUC(inf) after single dose and AUC (0-τ) after single and multiple doses Maximum blood concentration (Cmax)
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of the PK profile of ASKC189: blood concentration characteristics
Time to maximum blood concentration (Tmax)
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of the PK profile of ASKC189: steady state characterization
Accumulation ratio (AR) at steady-state
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of the PK profile of ASKC189: drug level characterization in blood
Apparent clearance (CL/F) after single and multiple doses
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
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Characterization of the PK profile of ASKC189
ASKC189 apparent terminal half-life (t1/2)
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR (based on RECIST Version 1.1).
Time frame: Up to approximately 3 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1).
Time frame: Up to approximately 3 years
Duration of Response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Overall survival (OS)
OS defined as the time from the first dose to death from any cause.
Time frame: Up to approximately 3 years