Safety, Tolerability, and Immunogenicity of LK101 Alone in Participants With Incurable Solid Tumors

Inclusion Criteria:

• signed informed consent.
• Age 18-75.
• life expectancy ≥3 months.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Subjects with histologically or cytologically confirmed advanced or metastatic solidtumors, unresponsive to standard treatment or for whom no standard treatment isavailable or appropriate.
• The sequencing of the tumor was qualified.
• Subject must have measurable diseases as per RECIST v1.1 criteria.
• According to the investigator's judgment, venous vascular conditions can meet theneeds of apheresis.
• Adequate bone marrow, renal, and hepatic at screening and at Baseline.

Exclusion Criteria:

• Patients who have received therapeutic tumor vaccine products (including peptidevaccine, mRNA vaccine, DC vaccine, etc.).
• Diagnosis of malignant diseases other than study disease within 5 years beforescreening (except for malignant tumors that can be expected to recover aftertreatment).
• Patients received systemic antitumor treatment within 2 weeks before the apheresis, orreceive research drugs or device therapy.
• Received radiotherapy within 4 weeks prior to screening.
• Toxicity caused by previous treatment did not recover to CTCAE (version 5.0) Grade 1or below (except hair loss and peripheral neuropathy).
• Patients who have active brain metastases or cancerous meningitis.
• History of significant cardiovascular and cerebrovascular disease occurred in the 6months prior to screening, Any of the following cardiac criteria:
• Mean resting corrected QT interval (QTc) > 470 ms;
• Left ventricular ejection fraction (LVEF) ≤ 50%;
• American New York heart association (NYHA) heart function ≥ 2 or higher;
• serious arrhythmia;
• poorly controlled hypertension;
• other serious heart diseases;
• Patients with interstitial pneumonia, except those inactive and do not requirehormone therapy disease;
• Any of the following test results are positive: human immunodeficiency virus (HIV)antibody, treponema pallidum antibody, hepatitis C virus (HCV) antibody, hepatitis Bvirus (HBV) surface antigen (HBsAg), HBV DNA and novel coronavirus nucleic acid.
• Active tuberculosis (TB) during screening.
• Treatment with systemic steroids or other immunosuppressive agents within 14 daysprior to screening;
• Vaccination within 4 weeks prior to screening.
• Major injuries and/or surgery =< 4 weeks prior to screening.
• Persons with a history of psychotropic substance abuse and inability to abstain orwith a history of mental disorders.
• Pregnant or lactating women.
• Other conditions are regimented at the investigators' discretion.