A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors

Exclusion Criteria

• •Presence of brainstem, meningeal metastases, spinal cord metastases or compression；
• •Presence of active central nervous system (CNS) metastases；
• •Subjects with pleural effusion, pericardial effusion, or ascites that are clinically symptomatic or require repeated drainage；
• •Subjects with other malignant tumors within 3 years prior to screening；
• •Subjects with autoimmune diseases that require systemic treatment within 2 years before screening；
• •Subjects are positive for human immunodeficiency virus (HIV)；
• •Prior or current presence of non-infectious pneumonia/interstitial lung disease requiring systemic therapy with glucocorticoids；
• •Serious infection within 4 weeks prior to the first dose or the presence of any active infection requiring systemic anti-infective therapy.
• •Having received the following treatments prior to the first dose of study treatment:
• •1. Having received anti-tumor therapies such as biological agents, chemotherapy and other investigational drugs not approved for marketing within 3 weeks prior to the first dose of study treatment (Patient may be enrolled if the first dose of study treatment is more than 5 half-lives of the drug from the last anti-tumor therapy);
• •2. Having received small molecule targeted antineoplastic agents (e.g., tyrosine kinase inhibitor), or palliative local therapy for non-target lesions, or non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor) within 2 weeks prior to the first dose;
• •3. Having received herbal medicine with an anti-tumor indication within 1 week prior to the first dose;
• •4. Prior immunotherapy other than anti-PD-(L)1 therapy (Patients with prior immunotherapy against other targets may be enrolled after discussion and agreement with the sponsor).