A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors

Exclusion Criteria

• •1. Females with pregnancy or in lactation period
• •2. Patients with active hepatitis B, or active hepatitis C
• •3. HIV positive
• •4. Other active infections of clinical significance
• •5. Patients receiving in situ surgery within 3 months
• •6. Patients with the following previous or accompanying diseases:
• •• Patients diagnosed as severe autoimmune diseases that require long term (more than 2 months) treatment with systemic immunosuppressants (steroids), or diseases with immune-mediated symptoms, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), and autoimmune vasculitis
• •7. Patients with ≥Grade 2 peripheral neuronal diseases (according to NCI-CTCAE v5.0)
• •8. Patients with any mental illness, including dementia, mental changes, which may cause difficulties understanding the informed consent and related questionnaires
• •9. Patients with serious uncontrollable diseases, which may interfere with the therapies in this study
• •10. Patients with other active malignancies in the past 5 years excluding those with completely cured basal or squamous skin cancers, superficial bladder cancers or primary breast cancers without need of follow-up treatment
• •11. Patients receiving systemic steroids or steroid inhalants
• •12. Patients who have received tumor immunotherapy (including monoclonal antibody or cell therapy) in the past 4 weeks
• •13. Patients allergic to immunotherapies or related drugs
• •14. Patients with metastatic lesions in meninges or central nervous system, or clear evidence of central nervous system diseases with continous significant symptoms in the last 6 months
• •15. Patients with NYHA class II heart failure, or hypertension incontrollable by standard care, or medical history of myocarditis, or heart attack within a year
• •16. Patients who have received or are going to receive organ transplantation
• •17. Patients with active bleeding
• •18. Patients with incontrollable pleural or abdominal fluid that needs clinical treatment or intervention
• •19. Patients having undergone major surgery within 4 weeks or have not fully recovered from prior surgery
• •20. Patients that have received radiotherapy within 4 weeks, excluding those who received local irradiation for the peripheral bone metastatic lesions for more than 2 weeks, and recovered from all acute toxicities of radiotherapy
• •21. Patients that have received anthracyclines within 8 weeks
• •22. Patients as determined by the investigators to be inappropriate for the study