A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors

Exclusion Criteria21

• History of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
• Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is either symptomatic, untreated, or requires therapy.
• Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage within 4 weeks prior to the first dose of investigational product.
• Receipt of systemic corticosteroid treatment or any other form of immune suppressing treatment within 7 days prior to the first dose of investigational product.
• Active or prior history of definite inflammatory bowel disease.
• History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or presence of active or suspected ILD/pneumonitis.
• Active infections requiring systemic therapy within 2 weeks prior to the first dose of investigational product.
• Positive for human immunodeficiency virus (HIV) or presence of acquired immune deficiency syndrome (AIDS).
• Active Hepatitis B or C infection.
• Active pulmonary tuberculosis (TB).
• Major surgery, chemotherapy, definitive radiotherapy, target therapy, immunotherapy, or other anti-cancer therapy within 21 days prior to the first dose of investigational product.
• Palliative radiotherapy within 14 days prior to the first dose of investigational product, or receipt of radioactive drug within 56 days prior to the first dose of investigational product.
• Administration of live vaccine within 28 days prior to the first dose of investigational product.
• History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Receipt of antitumor Chinese herbal preparations or Chinese patent medicine within 7 days prior to the first dose of investigational product.
• Receipt of any other investigational drugs within 21 days prior to the first dose in this trial.
• History of hypersensitivity or idiosyncrasy to the excipients of the study drug or any monoclonal antibody.
• Any toxic effects of prior therapy or surgical procedures unresolved to baseline severity or NCI-CTCAE Version 5.0 Grade ≤ 1.
• Active alcohol or drug abuse.
• Female participants who are pregnant or breastfeeding.
• Other acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or investigational product administration.