Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors

Exclusion Criteria19

• Prior anticancer treatment within 4 weeks prior to the first dose of study drugs;
• Toxicity from prior anticancer therapy prior to the first dose of study drugs not recovered to ≤ grade1;
• Hypertension did not satisfactory controlled after antihypertensive medication
• Phase Ib/II: Subjects who were previously treated with Lenvatinib or who participated in a clinical trial of a generic version of Lenvatinib
• Phase II cohort 1, intolerance to treatment with A PD-(L)1 inhibitor; History of severe digestive disease that can affect the oral absorption of Lenvatinib/Sunitinib;
• Uncontrollable or significant cardiovascular or cerebrovascular disease;
• Active, known history or suspected autoimmune disease;
• Have used or require treatment with \>10 mg/day of prednisone or an equivalent dose of systemic corticosteroids within 14 days prior to the first dose of study drugs;
• have received live attenuated vaccine within 28 days prior to the first study drug treatment or are scheduled to receive it during the study period;
• Subjects with known or suspected interstitial pneumonia;
• Any serious active infection requiring systemic antibacterial, antifungal or antiviral therapy at screening, including active tuberculosis; Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
• Active hepatitis B or hepatitis C;
• Known history of severe gastrointestinal bleeding or active hemoptysis or other severe bleeding within 6 months prior to first study drug therapy;
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage ;
• Known active or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis;
• Have other primary malignancies within 5 years;
• Known history of contraindications or hypersensitivity reactions to any investigational drug component or any known excipients
• Women who are pregnant or breastfeeding.
• Radiographic evidence of major blood vessel invasion/infiltration may be considered for enrollment if the investigator assesses that the risk is manageable.