Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.
Eligibility Criteria
Inclusion Criteria: Subjects Should have been previously treated with a third-generation EGFR TKI with disease progression. Subjects with positive other driver genes or METex14 mutations are required to undergo targeted therapy and disease progression. Exclusion Criteria: Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study.Patients are allowed to receive inactivated vaccines. Uncontrolled diseases including: * Infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose of the study drug（ antiviral medication for hepatitis B and hepatitis C infection that are compliant with the protocol were allowed）; * Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab positive); * Acute or chronic active hepatitis B (HbsAg positive and/or HbcAb positive with HBV DNA titer ≥ 104 copies/mL or ≥ 2000 IU/mL or higher than lower limit of detection)