A Phase 1/2 Study of TY101 for Locally Advanced /Metastatic Solid Tumors and Relapsed or Refractory Lymphomas

Exclusion Criteria

• •1. Previously received any of the following therapies:
• •1.1 Received any other cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose; for nitrosoureas and mitomycin C at least 6 weeks.
• •1.2 Received any targeted or other anticancer drug therapy within 4 weeks prior to the first dose.
• •1.3 Radiation therapy within 4 weeks prior to first dose (note: palliative radiotherapy for bone or palliative radiotherapy for superficial lesions was allowed, the course of treatment is based on local standards and had been ended 2 weeks before the first dose. Radiotherapy covering more than 30% of the bone marrow area within 4 weeks prior to first dose was excluded).
• •1.4 NMPA-approved antitumor Chinese traditional medicine is in use or has been used within 2 weeks prior to the first dose.
• •2. Concurrent malignancy within 5 years prior to screening, except for the cured basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• •3. Patients with active central nervous system (CNS) metastasis and/or cancerous meningitis who were found on known or in the screening tests, except for the following subjects: Subjects with asymptomatic brain metastasis who need to undergo regular brain imaging examination as the site of the disease. Subjects with stable status of brain metastasis after treatment.
• •4. Concomitant active or suspected autoimmune disease; but patients who are in a stable state and did not require systemic immunosuppressive therapy are allowed to be enrolled.
• •5. A history of allogeneic organ, bone marrow transplant or stem cell transplant; A history of allogeneic organ, bone marrow or stem cell transplantation.
• •6. Patients with the history of or are suffering from pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe pulmonary function impairment, etc., which may interfere with the detection and management of suspected drug-related pulmonary toxicity; patients with active tuberculosis or with a history of active tuberculosis infection ≤48 weeks prior to screening, regardless of treatment.
• •7. Severe cardiovascular disease, such as NYHA class III or IV congestive heart failure. A history of myocardial infarction, poorly controlled arrhythmias (including QTc interphase ≥450 ms in men and ≥470 ms in women, as calculated by the Fridericia formula), or cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism in the 6 months prior to screening.
• •8. Uncontrolled hypertension (systolic blood pressure \>150 mmHg and diastolic blood pressure \> 100 mmHg), a history of hypertension crisis, or a history of hypertensive encephalopathy.
• •9. Uncontrolled endocrine diseases (diabetes, thyroid disease, etc.).
• •10. Patients with active peptic ulcer or hemorrhagic disease.
• •11. Seriously infected persons who need to be treated with systemic antiviral or antimicrobial treatment.
• •12. Pericardial effusion, pleural effusion and peritoneal effusion that remained uncontrolled after intervention.
• •13. Patients with any other severe, acute or chronic disease that the investigator considers to be likely to interfere with participation in the study or evaluation and which the investigator determines to be inappropriate for participation in the clinical trial.
• •14. HIV infection.
• •15. Active viral hepatitis patients are excluded. Patients with serologic evidence of chronic HBV infection (defined by a positive hepatitis B surface antigen test and a positive anti-hepatitis core antigen antibody test, and the HBV-DNA); HCV infection (defined by positive HCV antibody and HCV-RNA test).
• •16. The history of other therapies against immune checkpoint, such as anti-PD-1, anti-PD-L1, anti-CTLA-4 or anti-LAG-3.
• •17. Have received steroids or other systemic immunosuppressive therapy within 14 days prior to the first dose, or have to be treated while on trial; except the following: a) The use of topical or inhaled corticosteroids, b) Glucocorticoids are used in the short term (continuous use≤7 days) to prevent or treat non-autoimmune allergic diseases.
• •18. History of serious allergic reaction to treatment with another monoclonal antibody.
• •19. A history of alcohol, drug or substance abuse.
• •20. Major surgery within 4 weeks prior to screening or scheduled to undergo major surgery during the trial.
• •21. Live virus vaccine or attenuated vaccine within 30 days prior to first dose.
• •22. Be in the other clinical studies now, or have participated in other intervention clinical trials in the previous 4 weeks.
• •23. Pregnant or breast-feeding females.
• •24. Any condition that the investigator believes may not be appropriate for participating the study.