Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Advanced Solid Tumors & Hematologic Malignancies

Exclusion Criteria33

• Subjects with primary central nervous system (CNS) tumors or unstable CNS metastases.
• Subjects who have uncontrollable or major cardiovascular disease refer to protocol.
• Subjects who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence.
• Subjects who have active or history of interstitial lung disease or non-infectious pneumonia.
• Subjects with any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first administration of the study drug.
• HIV infection; Hepatitis C virus (HCV) antibody positive; HCV infection.
• History of active bleeding within 2 months before screening, or bleeding symptoms associated with application of anticoagulant drugs or other interventions.
• Have not recovered to CTCAE Grade 1 or better from the adverse events due to previous cancer therapies.
• Subjects who received systemic immunosuppressive drugs within 14 days prior to the first administration of the study drug.
• Subjects who require systemic treatment of corticosteroids or other immunosuppressive agents within 14 days prior to first dose.
• Has a history of severe allergic reactions to monoclonal antibodies.
• Subjects with any mental or cognitive impairment that may limit their understanding, implementation.
• Previous treatment with immune checkpoint inhibitors
• Autologous hematopoietic stem cell transplantation within 100 days prior to first investigational medications dose, or history of allogeneic hematopoietic stem cell transplantation.
• Subjects currently suffering from acute graft-versus-host disease (GVHD) or active chronic GVHD.
• Have had any therapy directed against the subject's underlying cancer within 28 days prior to first investigational medications dose.
• Received other clinical trial drugs within 28 days prior to first investigational medications dose.
• Subjects who experienced major organ surgery (except for needle biopsy) or significant trauma within 28 days prior to first investigational medications administration, or who need selected surgical procedures during the study.
• Subjects who have been vaccinated with live attenuated vaccine within 28 days prior to first investigational medications administration.
• Clinical evidence of central nervous system (CNS) metastasis will be excluded.
• Previous or concomitant with CNS diseases.
• History of another primary malignancy not in remission for at least 2 years.
• Any severe active infection requiring systemic antimicrobial therapy.
• Active hepatitis B or C virus infection.
• History of immunodeficiency, including human immunodeficiency virus (HIV) antibody positive or known syphilis infection.
• History of severe cardiovascular and cerebrovascular diseases.
• Subjects who currently or have suffered from severe interstitial lung disease.
• The toxicity of previous anti-tumor therapy is still ≥ grade 2 at enrollment.
• History of severe bleeding disorders,.
• Known alcohol or drug dependence.
• Subjects with mental disorders or poor compliance.
• Pregnant or lactating female subjects.
• Any other condition that, in the opinion of the investigator or project clinician, would interfere with a subject's ability to receive or complete the study.