A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours

Inclusion criteria

• Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
• Aged 18-80 years old (including boundary values) , 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, or currently lack or are intolerant of, standard therapy.
• Subjects must have Archived Samples or fresh tumor tissue specimens are required for testing.
• At least one evaluable lesion.
• Subjects must show appropriate organ and marrow function inlaboratory 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.

Single-agent dose of 6mg/kg, 12mg/kg and and combined cohort：Subjects tested positive for biomarkers.

Exclusion criteria

• Previously received with same target therapy.
• Subjects has participated in any other interventional clinical trial within 28 days prior to the first dosing of LM-2417.
• Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-2417, 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.
• Subject who have uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• Subjects with known hypersensitivity to antibody therapy;
• Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) for more than 7 days or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-2417.
• Previous or current known autoimmune disease.
• 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 vaccine or live attenuated vaccines within 28 days prior to the first dosing of LM-2417.;
• Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists.
• Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of LM-2417.
• Subject who have history of severe cardiovascular disease.
• Subjects who have uncontrolled or severe illness.
• HIV infection, active HBV or HCV infection.
• 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.