Overview

The purpose of this study is to evaluate the safety，tolerability, pharmacokinetics, and preliminary efficacy of KC1036 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into three parts: dose-escalation phase, dose-expansion phase, RP2D-extension phase.

Eligibility

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.