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 solid tumors, unresponsive to standard treatment or for whom no standard treatment is available 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 the needs of apheresis.
* Adequate bone marrow, renal, and hepatic at screening and at Baseline.

Exclusion Criteria:

* Patients who have received therapeutic tumor vaccine products (including peptide vaccine, mRNA vaccine, DC vaccine, etc.).
* Diagnosis of malignant diseases other than study disease within 5 years before screening (except for malignant tumors that can be expected to recover after treatment).
* Patients received systemic antitumor treatment within 2 weeks before the apheresis, or receive 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 1 or 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 6 months 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 require hormone therapy disease;
* Any of the following test results are positive: human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis C virus (HCV) antibody, hepatitis B virus (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 days prior 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 or with a history of mental disorders.
* Pregnant or lactating women.
* Other conditions are regimented at the investigators' discretion.