A Study of LM-350 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.
• Participant must be ≥18 years or the legal age of consent at the time of signing the ICF.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Life expectancy ≥ 3 months.
• Patients with advanced solid tumors confirmed by histopathological diagnosis who have failed standard treatment, are intolerant to standard treatment, or for whom standard treatment is currently unsuitable.
• Pre-treatment archived tumour tissue (within 3 years) or on-treatment tumour biopsy could be provided for biomarker analysis.
• Must have at least one measurable lesion according to RECIST v1.1.
• Adequate organ and bone marrow function as defined by protocol.
• Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Exclusion criteria

• Participate in any other clinical trial within 28 days prior to 1st dosing of LM-350.
• Subjects who have received treatment with the same targeting.
• History of ≥ Grade 3 late diarrhea during or after previous treatment with a topoisomerase inhibitor.
• Subjects who have received the following anti-tumor treatments within the specified time periods prior to the first dosing of LM-350.
• Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
• Subjects with uncontrolled tumour-related pain.
• Subjects with known central nervous system (CNS) or meningeal metastasis.
• Subjects who have clinically uncontrollable third-space fluid accumulation.
• Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.
• Subjects who take systemic corticosteroids (≥ 10 mg/day of prednisone or equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dose of LM-350.
• Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
• Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, and any autoimmune, or prior pneumonectomy.
• Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-350.
• Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for > 2 weeks prior to the first dose of LM-350.
• Subjects with active or a documented history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease).
• Subjects with complete or incomplete intestinal obstruction within 3 months prior to the first dose of the study drug , orpatients who are currently at the risk of intestinal perforation.
• Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-350.
• Subjects who have severe cardiovascular disease.
• Subjects who have uncontrolled or severe illness.
• Subjects who have a history of immunodeficiency disease.
• HIV infection, active infection including tuberculosis, HBV and HCV infection.
• Subjects who have other active malignancies which are likely to require the treatment.
• Child-bearing potential female who have positive results in pregnancy test or are lactating.
• Subjects who have psychiatric illness or disorders that may preclude study compliance.
• Subject who is judged as not eligible to participate in this study by the investigator.