The purpose of this study is to evaluate the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with Esophageal Squamous Cell Carcinoma. The study is divided into three parts: the safety run-in phase, randomized enrollment phase and cohort expansion phase.
Age ≥18 years and ≤75 years
Safety run-in phase (Cohort 1, 2 and 3): received no more than 1 prior line of systemic therapy for locally advanced or metastatic ESCC.
Safety run-in phase (Cohort 4), randomized enrollment phase and cohort expansion phase: no prior systemic therapy for locally advanced or metastatic ESCC.
Participants are required to provide tumor tissue samples for biomarker analysis.
Histology or cytology confirms the presence of concurrent adenocarcinoma components.
Leptomeningeal, brainstem, spinal, spinal cord compression, or active CNS metastases.
Risk of esophagotracheal/esophagopleural fistula, or symptomatic invasion/compression of vital organs/major blood vessels.
Active autoimmune disease requiring systemic therapy within past 2 years.