The Efficacy and Safety of IBI363 in Solid Tumors
Trial Parameters
Brief Summary
The study is a prospective multi-cohort clinical study. The study is divided into two phases, Phase Ia and Phase Ib. In Phase Ia, a dose escalation portion was conducted using a 3+3 dose-escalation design, with a preference for enrolling subjects with advanced non-small cell lung cancer and melanoma. Phase Ib represents the cohort expansion phase, comprising seven cohorts.
Eligibility Criteria
Inclusion Criteria: * Sign written informed consent before implementing any trial-related procedures * Age ≥18 years old and ≤75 years old; * No limit on the gender; * Phase Ia: Enrollment priority is given to subjects with advanced non-small cell lung cancer and melanoma. * Phase Ib: This study comprises seven cohorts, including: * Cohort A: Patients with histopathologically confirmed advanced melanoma, who have failed PD-1/PD-L1 treatment and CD73 ≥++ confirmed by IHC. * Cohort B: Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment and CD73 ≥++ confirmed by IHC. * Cohort C: Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment, and whose best response during PD-1/PD-L1 treatment was disease stabilization for less than 6 months or disease progression. * Cohort D: Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment, and whose best response during PD-1/PD-