Inclusion Criteria:
1. Subjects who are fully informed of the purpose, nature, method and possible adverse
reactions of the study, and are willing to participate in the study and sign the
informed consent form (ICF) prior to any study related procedures.
2. Aged ≥18 years old when sign the ICF, male or female.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no
deterioration within 2 weeks prior to the first dose.
4. Life expectancy ≥ 3 months.
5. Subjects must have histological or cytological confirmation of recurrent or refractory
advanced solid tumors, and have progressed on standard therapy, or are intolerable for
available standard therapy, or there is no available standard therapy.
6. Formalin-fixed paraffin-embedded (FFPE) tumor tissue samples meet the minimum
requirements.
7. At least one measurable lesion according to RECIST v1.1.
8. Subjects must show appropriate organ and marrow function in laboratory examinations
within 7 days prior to the first dose.
9. Subjects who are able to communicate well with investigators and understand and adhere
to the requirements of this study.
Exclusion Criteria:
1. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-24C5.
2. Any prior treatments towards the investigational target.
3. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-24C5,
including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy,
etc. the following treatments have different time limits.
4. Any adverse event from prior anti-tumor therapy has not yet recovered to≤ grade 1 of
CTCAE v5.0.
5. Subjects with uncontrolled pain.
6. Subjects with known central nervous system (CNS) or meningeal metastasis.
7. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites
requiring recurrent drainage procedures.
8. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that
contains any monoclonal antibody.
9. Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or
other systemic immunosuppressive medications within 2 weeks prior to the first dosing
of LM-24C5.
10. Subjects with the known history of autoimmune disease.
11. Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia,
drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on
screening chest CT scan.
12. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-24C5.
13. Subjects who are taking therapeutic doses of anticoagulants such as heparin or vitamin
K antagonists for presence of active thromboembolic disease.
14. Subjects who received major surgery or interventional treatment within 28 days prior
to 1st dosing of LM-24C5.
15. Subjects who have severe cardiovascular disease.
16. Subjects who have uncontrolled or severe illness, including but not limited to ongoing
or active infection
17. Subjects who have a history of immunodeficiency disease, including other acquired or
congenital immunodeficiency diseases, or organ transplantation, or allogeneic bone
marrow transplantation, or autologous hematopoietic stem cell transplantation.
18. HIV infection, active infection including tuberculosis, HBV and HCV infection, with
the exception:
19. Subjects who have other active malignancies which are likely to require the treatment.
20. Child-bearing potential female who have positive results in pregnancy test or are
lactating.
21. Subjects who have psychiatric illness or disorders that may preclude study compliance.
22. Subject who is judged as not eligible to participate in this study by the
investigator.
