This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
206
Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.
Jilin Cancer Hospital
Jilin City, China
NOT_YET_RECRUITINGShanghai East Hospital, Tongji University
Shanghai, China
RECRUITINGNumber of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
adverse events (AEs) and serious adverse events (SAEs), dose-limiting toxicities (DLTs), clinically significant abnormal laboratory results, etc.
Time frame: From enrollment to the end of treatment at 24 months
ORR(objective response rate)
ORR as assessed by the investigator based on RECIST v1.1
Time frame: From enrollment to the end of treatment at 24 months
DCR(Disease control rate )
as assessed by the investigator based on RECIST v1.1
Time frame: From enrollment to the end of treatment at 24 months
DOR(duration of response )
as assessed by the investigator based on RECIST v1.1
Time frame: From enrollment to the end of treatment at 24 months
PFS(progression-free survival)
as assessed by the investigator based on RECIST v1.1
Time frame: From enrollment to the end of treatment at 24 months
OS (overall survival)
Time frame: From enrollment to the end of treatment at 24 months
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