This study is divided into two phases: dose escalation and cohort expansion. The dose escalation stage aims to evaluate the tolerability, pharmacokinetic characteristics and safety of TQB2858 injection in subjects with advanced malignant tumors. The cohort expansion phase aims to evaluate the initial efficacy and safety of TQB2858 injection in patients with soft tissue sarcoma, and to explore treatment-related biomarkers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
TQB2858 is a Programmed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β(TGF-β) double antibody.
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Maximum tolerated dose (MTD)
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.
Time frame: Baseline up to 48 weeks
Overall response rate (ORR)
ORR refers to the percentage of complete response (CR) or partial response (PR) subjects determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or iRECIST (CR and PR under iRECIST criteria can occur after imaging disease progression).
Time frame: up to 48 weeks
Disease control rate(DCR)
DCR refers to the percentage of subjects with CR, PR, or stable disease (SD) of 6 weeks or more as determined by RECIST 1.1 or iRECIST (CR, PR, SD under iRECIST criteria can occur after imaging disease progression).
Time frame: up to 48 weeks
Overall survival (OS)
OS is defined as the time from enrollment to death from any cause.
Time frame: Baseline up to die
Progression-Free Survival (PFS)
PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first.
Time frame: up to 48 weeks
Duration of Response (DOR)
DOR will be defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes.
Time frame: up to 48 weeks
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West China Hospital,Sichuan University
Chengdu, Sichuan, China