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
Aged ≥18 years old at the time of informed consent
Able to provide informed consent voluntarily before any study-related activities and according to local guidelines
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Have an estimated life expectancy ≥ 12 weeks
Are currently enrolled in a clinical study involving an investigational product or any other type of medical research
Have tumors previously tested positive for Class I BRAF mutations i.e. V600X
Prior treatment with a pan-RAS(ON) inhibitor
Gastrointestinal conditions that may interfere with drug absorption
Single group
ASKC189
DrugASKC189 for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met.
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.
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.
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)
Characterization of the PK profile of ASKC189: blood concentration characteristics
Time to maximum blood concentration (Tmax)
Characterization of the PK profile of ASKC189: steady state characterization
Accumulation ratio (AR) at steady-state
Characterization of the PK profile of ASKC189: drug level characterization in blood
Apparent clearance (CL/F) after single and multiple doses
The identification of potential predictive biomarkers associated with response or resistance to ASKC189
Correlation of clinical outcomes with biomarkers to specific RAS mutation subtypes, and co-mutations in tumor tissue at baseline and progressive disease.
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