A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN1

This is an interventional treatment trial for Advanced Solid Tumor Read More

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 75 years old, male or female;
2. Subjects with histologically or cytologically diagnosed advanced malignant solid tumors or B-cell lymphoma who have failed on, or are intolerant to, standard therapy, for whom there are no standard of care regimens, or who are otherwise not eligible for standard therapy at this stage;
3. Subjects with Eastern Cooperative Oncology Group (ECOG) performance score of 0-1;
4. Females must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception from screening until the end of the follow-up period.
5. Subjects must be able to understand and sign the paper informed consent before any study specific procedure.

Exclusion Criteria:

1. Received anti-tumor treatment such as radiotherapy, chemotherapy, biotherapy, endocrine therapy, immunotherapy, etc., within 4 weeks prior to the first dose of study drug.
2. Received other investigational agents (not yet approved by any regulatory agency) within 4 weeks prior to the first dose of study drug;
3. Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose of study drug;

4. Systemic application of corticosteroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of study drug;

   • Exceptions: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids, or short-term corticosteroids for prophylaxis (e.g., contrast allergy prophylaxis).
5. Use of live attenuated vaccine within 4 weeks prior to the first dose of study drug;
6. Clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the central nervous system or meninges of the subject;
7. Active infection and in current need of, or likely to need, intravenous anti-infective therapy;
8. History of immunodeficiency, including history of any positive test result for human immunodeficiency virus (HIV) antibody;
9. Active hepatitis B or hepatitis C virus infection.
10. Subjects with active or previous autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except subjects with clinically stable autoimmune thyroid disease;
11. Subjects with mental disorders or other conditions that pose high non-compliance risks in the opinion of the investigator;