A Study of KM501 in Patients With Solid Tumors

Subjects with known clinical or untreated central nervous system metastases, including meningeal metastases. Does not include: After radiation therapy, MRI/CT examination at least 4 weeks prior to initial administration of the trial drug (showing stable lesions, no uncontrollable neurological symptoms or signs (e.g., epilepsy, headache, central nausea/vomiting, progressive neurological dysfunction, papilledema), or any treatment that does not require local (e.g., radiation) and systemic (e.g., Untreated asymptomatic brain metastases of mannitol or corticosteroids;

Subjects with other malignancies within 5 years prior to initial administration of the experimental drug, except those with basal cell carcinoma, local squamous cell carcinoma of the skin, cervical carcinoma in situ, etc., who have not relapsed and metastasized after radical treatment;

Subjects who have received chemotherapy, targeted therapy, or other systematic antitumor therapy within 4 weeks or 5 half-lives (whichever is older) prior to the initial administration of the test drug, and who have been treated with Chinese herbal or proprietary drugs for antitumor purposes within 2 weeks prior to the initial administration;

Subjects who required systematic treatment with a dose of a corticosteroid >10 mg/ day equivalent to prednisone (see Appendix 9 for dose conversion) or other immunosuppressant within 14 days prior to initial administration of the trial drug or during the study period. Inhaled or topical doses ≤10 mg/ day equivalent to prednisone are permitted in the absence of active autoimmune disease. Short-term use of corticosteroids in doses >10 mg/ day equivalent to prednisone is permitted for the prevention (e.g., contrast allergy) or treatment of non-autoimmune diseases (e.g., delayed hypersensitivity caused by exposure to allergens);