A Study of KC1086 in Patients With Advanced Solid Tumors

Inclusion criteria

• Histologically or cytologically confirmed recurrent or metastatic solid tumors;
• Patients who have failed standard or conventional treatment or for whom no standard treatment is available( definition of treatment failure: intolerable toxic and side effects, disease progression during treatment recurrence after treatment);
• Participants with advanced recurrent, unresectable, and/or metastatic tumors must have evaluable or measurable lesions (according to RECIST 1.1)；
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Life expectancy > 12 weeks;
• Adequate bone marrow, renal, and hepatic function;
• Patients should participate in the study voluntarily and sign informed consent.

Exclusion criteria

• Any patient who is known to have untreated central nervous system (CNS) metastasis;
• Other kinds of malignancies within 5 years;
• Gastrointestinal abnormalities;
• Cardiovascular and cerebrovascular diseases;
• Involved in other clinical trials within 4 weeks before enrollment;
• Prior anti-tumor therapies with radiotherapy, immunotherapy, operation within 4 weeks before enrollment;
• Prior anti-tumor therapies with small molecule targeting drugs within 2weeks or 5 half-lives (whichever is longer) before enrollment; Prior anti-tumor therapies with chemotherapy within 3 weeks or 5 half-lives (whichever is longer) before enrollment;
• Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;
• Severe infection within 4 weeks prior to enrollment;
• Uncontrolled massive ascites, pleural or pericardial effusion；
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;
• Prior therapies with KAT6 inhibitors
• Pregnant or lactating women;
• Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study.
• Other patients are not eligible for enrollment assessed by investigators.