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

• Status: Recruiting
• Trial end date: 2026-03-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-labeled, single-center phase I study in patients with incurable advanced solid tumors, who failed with all previous standard therapy. The aim is to observe and evaluate the safety, tolerability, and immunogenicity of LK101 injection.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Likang Life Science and Tech Co., Ltd.

Criteria

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.