This study is the first-in-human of ASKC202, which is an open-label, non-randomized, multicenter study with a dose escalation phase and a dose expansion phase.
Willing and able to provide signed and dated informed consent;
Aged 18 years old or more, male or female;
Part 1 (Monotherapy Dose-Escalation) and Part 3 (Monotherapy Expansion): the subjects with locally advanced or metastatic solid tumors for whom no standard therapy regimens are available currently or who are intolerable to standard therapy regimens; Part 3: the subjects with MET gene amplification or protein overexpression; Part 3 cohort 1: histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC.
Have previously received or are receiving any treatment for c-Mets (including all monoclonal antibodies or small molecule drugs targeted at the target, except for crizotinib);
Have received chemotherapy, hormone therapy, immunotherapy, or biological therapy such as antibody therapy within 4 weeks prior to the first dose, or traditional Chinese medicine with anti-tumor indications within 2 weeks, or small molecule targeted therapy with an interval of less than 5 half-lives; palliative radiotherapy within 7 days or extensive/therapeutic radiotherapy within 14 days prior to the first dose;
Those who still need to continue to use systemic immunosuppressants or systemic corticosteroids (≥ 10 mg of prednisone or its equivalent other corticosteroid) for 2 weeks prior to the first dose;
Patients who have used strong inhibitors or strong inducers of CYP3A within 2 weeks prior to the first administration, or who need to continue treatment with these drugs during the study period;
Single group
ASKC202
DrugDosage Forms: Tablets; Administration: Oral administration
ASK120067
DrugDosage Forms: Tablets; Administration: Oral administration
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.
Maximum Tolerated Dose (MTD）
The MTD was defined as the highest dose of ASKC202 not causing DLT in more than 33% of patients in the first treatment cycle.
Number of participants with adverse events and serious adverse events as assessed by CTCAE v5.0
An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs include both Serious TEAEs and non-serious TEAEs. Number of Participants with TEAEs and serious TEAEs were reported.
Pharmacokinetics:maximum Plasma Concentration [Cmax]
Serum samples will be collected for Cmax analysis.
Pharmacokinetics:terminal elimination half life (T1/2)
Serum samples will be collected for T1/2 analysis.
Pharmacokinetics:Area Under Curve (AUC)
Serum samples will be collected for AUC analysis.
ORR
Objective response rate (ORR) is defined as the percentage of complete response (CR) or partial response (PR), as determined according to RECIST v1.1.
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