A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors

Inclusion criteria

• Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
• Aged ≥18 years old, male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Life expectancy ≥ 3 months.
• Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy.
• At least one evaluable lesion.
• Subjects in the combination therapy group must have Archived Samples or fresh tumor tissue specimens are required for testing.
• Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose:
• Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception prior to study entry, during the study and for 6 months after the last dose of study drug.
• Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.

Exclusion criteria

• Subject has received prior investigational therapy directed at the same target therapy.
• Subjects has participated in any other interventional clinical trial within 21 days prior to the first dosing of LM-101.
• Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-101, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc.
• Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
• Poorly controlled tumor-related pain.
• Subjects with symptomatic/active central nervous system (CNS) metastases.
• Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
• Subjects with known hypersensitivity to antibody therapy.
• Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medicationswithin 2 weeks prior to the first dosing of LM-101.
• Subjects with the known history of autoimmune disease with the exception of subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone.
• Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
• Use of any live attenuated vaccines within 28 days prior to the first dosing of LM-101.
• Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists.
• Subjects who received major surgery or interventional treatment within 28 days prior to the first dosing of LM-101 (excluding tumor biopsy, puncture, etc.).
• Subjects who have history of severe cardiovascular disease.
• Subjects who have uncontrolled or severe illness.
• Subjects who have a history of immunodeficiency disease.
• HIV infection, active tuberculosis or active HBV and HCV infection.
• Subjects who have Known history of active tuberculosis.
• Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening.
• Child-bearing potential female who have positive results in pregnancy test or are lactating.
• Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.
• Subject who is judged as not eligible to participate in this study by the investigator.