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.
Parallel
SKB500
DrugSKB500 will be administered as an intravenous infusion(IV), every 3 weeks on Day 1 of each 21-day cycle.
Tislelizumab
DrugTislelizumab will be administered as an intravenous infusion(IV) every 3 weeks on Day 1 of each 21-day cycle .
Cisplatin
DrugCisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
5 - FU
Drug5-FU will be administered as an intravenous infusion(IV) every 3 weeks on Day 1-5 of each 21-day cycle.
Objective Response Rate (ORR)
Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by investigator based on RECIST version 1.1.
Incidence and severity of adverse events (AEs) and serious adverse event(SAEs)
Incidence and severity of adverse events (AEs) and serious adverse event(SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v6.0, as well as clinically significant abnormal laboratory findings.
Progression-free survival (PFS)
Progression-free survival (PFS) was defined as the time from baseline to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
Duration of response (DOR)
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response\[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DOR was measured for responding participants (PR or CR) only.
Disease control rate (DCR)
Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate.
Overall Survival (OS)
The time from first dose to death from any cause.
Biomarkers
Correlation between the expression level of PD-L1, B7-H3, SLFN11 in tumor tissues and the efficacy.
Click on the lead sponsor to view all of their trials.
