Safety and Toxicity Study of IMM27M in Patients With Advanced Solid Tumor

Who cannot join

• Treatment with the last systemic anti-tumor therapy within 4 weeks prior to the first administration, including chemotherapy, immunotherapy, biotherapy and so on; treatment with hormone anti-tumor therapy and small-molecule targeted therapy within 2 weeks prior to the first administration; palliative local treatment for non-target lesions within 2 weeks prior to the first administration; treatment with non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks prior to the first administration; treatment with Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week prior to the first administration.
• Treatment with anti-CTLA-4 inhibitors and anti-PD-1/L1 inhibitors 4 weeks before the first administration;
• Patients with primary central nervous system (CNS) malignant tumors or patients with active metastasis of CNS after local treatment failure (radiotherapy or surgery), but the following patients are allowed to be enrolled: a. Asymptomatic brain metastases; b. Clinical symptoms are stable (i.e., no radiographic progression and all neurological symptoms have returned to baseline 4 weeks before the first administration), and no corticosteroid treatment and other treatments for brain metastasis are required ≥ 4 weeks;
• Hypertension (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg), pulmonary hypertension or unstable angina, which cannot be controlled by medication; treatment with myocardial infarction, bypass or stent surgery within 6 months prior to administration; a history of chronic heart failure rated by the New York Heart Association (NYHA) as grade 3-4; valvular disease with clinical significance; severe arrhythmia requiring treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia), including QTcF≥450ms for male and ≥470ms for female (calculated by Fridericia formula); cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 12 months prior to enrollment;
• A history of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 3 months prior to administration;
• A history of moderate or severe dyspnea at rest due to an advanced malignant tumor or its complications or severe primary pulmonary disease, or a current need for continuous oxygen therapy, or a current history of interstitial lung disease (ILD) or pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.;