A Prospective, Multi-cohort Study on Efficacy and Safety of IBI363 for Advanced Solid Tumors
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.
• 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-L1 treatment was partial response or complete response lasting more than 6 months.
• Cohort E: Patients with histologically confirmed advanced NSCLC, who have undergone NGS testing confirming the presence of an ALK fusion mutation and have previously failed standard treatment.
• Cohort F: Patients with histological or cytological confirmation of advanced NSCLC who harboring EGFR mutation and failed standard treatment.
• Cohort G: Patients with histological or cytological confirmation of advanced NSCLC and failed standard treatment with rare mutations, including but not limited to ROS1, BRAF V600E, METex14 skipping, HER2, NTRK, and RET fusion.
• Tumor assessment according to RECIST v1.1, at least one measurable lesion.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1