The purpose of this study is to evaluate the preliminary efficacy, safety, tolerability and pharmacokinetics of KC1036 in participants with advanced recurrent or metastatic digestive system tumors.
Histologically or cytologically confirmed malignant digestive system tumors;
Patients with advanced recurrent, unresectable and / or metastatic digestive system tumors who have failed standard or conventional treatment:( definition of treatment failure: intolerable toxic and side effects, disease progression during treatment recurrence after treatment);
Eastern Cooperative Oncology Group performance status score of 0 or 1;
Life expectancy > 12 weeks;
Any patient who is known to have central nervous system (CNS) metastasis with clinical symptoms;
Other kinds of malignancies;
Gastrointestinal abnormalitiest;
Cardiovascular and cerebrovascular diseases;
Parallel
KC1036
DrugKC1036 are administered orally QD or BID in 21-day cycles.
Objective Response Rate (ORR)
Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1.
Progression-free survival (PFS)
Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.1 or death due to any cause.
Disease Control Rate (DCR)
Disease Control Rate (DCR) was defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.
Duration of Response (DOR)
Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.1.
Pharmacokinetics (PK) profile: Cmax
Parameters: Peak Plasma Concentration
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