This a multi-center, open-label, non-randomized phaseⅠb trail. The purpose of this study was to evaluate the efficacy and safety of QL1706 in patients with advanced solid tumors and to investigate the immunogenicity and pharmacokinetic characteristics of QL1706.
The study was divided into screening/baseline, treatment and follow-up periods. Efficacy assessment and safety monitoring will be conducted throughout the study period. Subjects will continue study treatment until disease progression occurs (unless the investigator believes there is a sustained clinical benefit) or other criteria for discontinuing study treatment are met, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
419
5 mg/kg, IV, Q3w
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
objective response rate (ORR)
ORR includes complete response (CR) and partial response (PR) cases. According to RECIST V1.1, the first appearance of PR or CR requires additional imaging to confirm the lesion at ≥4 weeks.
Time frame: up to 24 weeks
disease control rate (DCR)
DCR refers to the percentage of the cases in which the best efficacy rating is complete response (CR) or partial response (PR) or stable disease (SD).
Time frame: up to 24 weeks
progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time between a subject's first infusion QL1706 injection and their first radiographic evaluation of disease progression or death from any cause, whichever comes first.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
overall survival time (OS)
Overall survival (OS) is the time between the subject's first infusion QL1706 injection and death from any cause.
Time frame: From date of enrollment until the date of death from any cause, assessed up to 24 months
adverse event (AE)
The rates and severity of AEs after QL1706 injection
Time frame: up to 90 days after the last QL1706 injection is administered.
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