A Study of KC1036 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, Including chemotherapy, targeted therapy, immunotherapy:

Documented disease progression after, or refractory to, or intolerant of prior standard or established therapy known to provide clinical benefit for their condition; or documented disease progression within 24 weeks after prior adjuvant/neoadjuvant therapy;

• At least one measurable lesion (by RECIST 1.1);
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Life expectancy > 12 weeks;
• Patients should participate in the study voluntarily and sign informed consent.

Exclusion criteria

• Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks;
• Other kinds of malignancies;
• Hematologic, renal, and hepatic function abnormities;
• Risk of bleeding;
• Gastrointestinal abnormalitiest;
• Cardiovascular and cerebrovascular diseases;
• Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks of enrollment;
• Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE V5.0 grade 0 or 1 with the exception of alopecia;
• Involved in other clinical trials within 4 weeks of enrollment;
• Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks days of enrollment;
• History of organ allograft;
• Need immunosuppressive agents or systemic or absorbable topical hormone therapy for immunosuppression;
• Uncontrolled ongoing or active infection;
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;
• Pregnant or lactating women or those who do not take contraceptives, including men;
• Suffering from mental and neurological diseases;
• Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;
• Inability to comply with protocol required procedures.